Warsaw, IN, United States

Zimmer Biomet, Inc. recalls

95 recalls recorded since 2018, most recently on 20 November 2020. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls95

Ongoing (FDA)0

Terminated or completed95

Class I (FDA)1

Terminated Class II Medical devices

Recall started: 20 November 2020
Terminated: 26 May 2022
Reason: Device has the potential for fracture during use.
Distribution: Domestic distribution nationwide. Foreign distribution to Australia, China, Hong Kong, India, Japan, Korea, New Zealand, Taiwan, Singapore, Thailand, Canada, Netherlands, Argentina, Brazil, Mexico, Venezuela, Panama, and Chile.
Initiated: Voluntary: Firm initiated
Recall number: Z-0696-2021

Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.

Terminated Class II Medical devices

Recall started: 17 November 2020
Terminated: 27 July 2021
Reason: Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system.
Distribution: Domestic distribution nationwide. As direct stimulation devices are only available in the US, this contraindication does not apply to international customers.
Initiated: Voluntary: Firm initiated
Recall number: Z-0570-2021

Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system

Terminated Class II Medical devices

Recall started: 24 September 2020
Terminated: 20 May 2022
Reason: Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Distribution: US Nationwide
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0344-2021, Z-0368-2021, Z-0394-2021, Z-0363-2021, Z-0328-2021, Z-0370-2021, Z-0386-2021, Z-0348-2021, Z-0325-2021, Z-0374-2021, Z-0396-2021, Z-0357-2021 and 63 more

ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-32
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 00-8065-648-26
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 55 mm Number: 00-8065-952-32
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-22
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 47 mm Item Number: 00-8065-544-28
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 00-8065-648-32
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 00-8065-656-32
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-32
and 67 more product lines

Terminated Class II Medical devices

Recall started: 14 August 2020
Terminated: 9 June 2022
Reason: The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.
Distribution: Products were distributed to the following US states: FL, ID, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, OR, PA, SC, TX, UT, VA, WI, and WV.
Initiated: Voluntary: Firm initiated
Recall number: Z-0057-2021

Dual Mobility Vivacit-E Bearing, Model Number 110031009

Terminated Class II Medical devices

Recall started: 5 May 2020
Terminated: 15 July 2022
Reason: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
Distribution: US nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2214-2020, Z-2213-2020, Z-2231-2020, Z-2217-2020, Z-2216-2020, Z-2232-2020, Z-2224-2020, Z-2222-2020, Z-2211-2020, Z-2225-2020, Z-2210-2020, Z-2227-2020 and 13 more

Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number 810M5535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation,
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Number 810M4545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation,
Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation,
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number 810M5550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation,
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Number 810M5545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation,
Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Number 811M8560 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation,
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM, Item Number 810M6540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation,
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Number 810M6555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation,
and 17 more product lines

Terminated Class II Medical devices

Recall started: 7 January 2020
Terminated: 8 April 2021
Reason: Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.
Distribution: Domestic distribution to AL CA FL IA IL MD MI MN MO MS NC NE NJ NY PA TX UT VA WA WI
Initiated: Voluntary: Firm initiated
Recall number: Z-1347-2020

THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixatio

Terminated Class II Medical devices

Recall started: 23 December 2019
Terminated: 10 September 2020
Reason: Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed the expiration date on the inner label
Distribution: US Nationwide
Initiated: Voluntary: Firm initiated
Recall number: Z-0988-2020

Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00

Terminated Class II Medical devices

Recall started: 19 December 2019
Terminated: 11 August 2020
Reason: Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach
Distribution: US Nationwide and Foreign: countries of Canada, CHINA, NETHERLANDS
Initiated: Voluntary: Firm initiated
Recall number: Z-0871-2020

ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument

Terminated Class II Medical devices

Recall started: 12 December 2019
Terminated: 13 January 2021
Reason: The lot contained two outer pins instead of one outer and one inner pin.
Distribution: Distributed to accounts in California and Ohio.
Initiated: Voluntary: Firm initiated
Recall number: Z-1000-2020

Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained

Terminated Class II Medical devices

Recall started: 25 October 2019
Terminated: 30 April 2020
Reason: Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam
Distribution: Distribution to US states of CA, FL, IN, MN, MO, NY, and UT, Australia, and New Zealand
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0594-2020, Z-0595-2020

Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665

Terminated Class II Medical devices

Recall started: 10 October 2019
Terminated: 19 May 2020
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Distribution: Distributed nationwide.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0298-2020, Z-0330-2020, Z-0308-2020, Z-0325-2020, Z-0309-2020, Z-0335-2020, Z-0304-2020, Z-0329-2020, Z-0336-2020, Z-0326-2020, Z-0316-2020, Z-0328-2020 and 29 more

BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00430001213 004300012
Connection Screw for NCB Plate, Item No. 0202266002
PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110 00234700112 00234700114 00234700116 00234700118 00234700206 00234700208 00234700210 00234700212 00234700214 00234700216 00234700218
Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843 32855420307 32855420308 32855420309 32855420310 32855420315 32855430491 32855430497 32855430499 32855430500 32855430502 328554
Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308 47235700310 47235700312 47235700314 47235700408 47235700410 47235700412 47235700414 47235700416 47235700504 47235700506
Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003 00877004004 00877004005
NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 0202263112 0202263115 0202263118 0202263121 0202264009 0202264012 020226
Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 0202024301 0202024325 0202024330 0202024
and 33 more product lines

Terminated Class II Medical devices

Recall started: 21 August 2019
Terminated: 21 July 2021
Reason: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Distribution: US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0520-2020, Z-0533-2020, Z-0530-2020, Z-0523-2020, Z-0528-2020, Z-0525-2020, Z-0521-2020, Z-0532-2020, Z-0522-2020, Z-0526-2020, Z-0519-2020, Z-0527-2020 and 3 more

COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861 PM0001456 PM551047 PM551063 PM555137 PM555160 PM555209 PM555322 P
BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement
BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-103208 21-103209 21-103210 21-103211
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13
Comprehensive RS Cleat CAP, Item No. 110300
ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 1
and 7 more product lines

Terminated Class II Medical devices

Recall started: 15 August 2019
Terminated: 16 April 2021
Reason: The locking bar not fully engaging
Distribution: State NY IN OH MI GA SC FL MO WI MN ND SD NE NJ PA MD IL IA CA VA NC DC WV AR AL MS AL MI WA OR ID LA FL KS TN MA KY OK TX TX CT AZ NV NM MT WY CO UT DC WY Country: KOREA CHINA CANADA AUSTRALIA JAPAN EMEA SWEDEN ITALY
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2519-2019, Z-2525-2019, Z-2515-2019, Z-2534-2019, Z-2527-2019, Z-2528-2019, Z-2510-2019, Z-2513-2019, Z-2533-2019, Z-2518-2019, Z-2521-2019, Z-2514-2019 and 23 more

XP-XP Tibial Tray - Interlok 79 mm Item # 195758
XP-XP Tibial Tray - Interlok 65 mm Item # 195752
XP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291
Vanguard XP Tibial Tray 75 mm Item # 195251
XP-XP Tibial Tray - Interlok 59 mm Item # 195750
Vanguard XP Tibial Tray 63 mm Item # 195245
XP-CR Tibial Tray - Interlok 75mm Item # 195275
XP-CR Tibial Tray - Interlok 87 mm Item # 195278
and 27 more product lines

Terminated Class II Medical devices

Recall started: 6 August 2019
Terminated: 24 August 2020
Reason: The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331.
Distribution: CA, IN, MN, NJ, NY, AR, LA, OH, KY, TX, CO (US) CA, CN, NL (International)
Initiated: Voluntary: Firm initiated
Recall number: Z-0517-2020

ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331

Terminated Class II Medical devices

Recall started: 2 July 2019
Terminated: 10 September 2021
Reason: Cleaning processes potentially being ineffective
Distribution: Distributed to the following states in the USA: AZ, CA, DC, GA, IL, KY, LA, MA, MD, MN, NC, NJ, NM, OH,OK, OR, SC, TX. Distributed to Japan and Netherlands.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2233-2019, Z-2232-2019, Z-2236-2019, Z-2231-2019, Z-2234-2019, Z-2235-2019

Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151815
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814

Terminated Class II Medical devices

Recall started: 10 June 2019
Terminated: 10 September 2020
Reason: Lack of an adequate sterilization validation.
Distribution: The products were distributed US nationwide. The products were distributed to the following foreign countries: Argentina, Australia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, India, Japan, Korea, Malaysia, Mexico, Netherlands, Thailand, Venezuela.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1961-2019, Z-1960-2019

Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509

Terminated Class II Medical devices

Recall started: 4 June 2019
Terminated: 21 July 2021
Reason: The products do not have sufficient data to support the labeled shelf life of 10 years.
Distribution: Worldwide distribution - US nationwide distribution and countries of Australia, Brazil, Canada, Chile, China, Columbia, Hong Kong, India, Japan, Malaysia, Netherlands, and Taiwan.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1963-2019, Z-1962-2019

Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthope
Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic app

Terminated Class II Medical devices

Recall started: 28 May 2019
Terminated: 19 November 2021
Reason: There is a potential for weak seals of the sterile packaging.
Distribution: Worldwide Distribution - US Nationwide: AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH OK, OR, PA, SC, TN, TX, UT, WA, WI, WV, and Puerto Rico. Products were distributed to the following foreign countries: Australia, Canada, Chile, Japan, Netherla
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1946-2019, Z-1947-2019, Z-1948-2019

DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.

Terminated Class II Medical devices

Recall started: 18 April 2019
Terminated: 10 September 2020
Reason: Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Distribution: CA, IN, LA, NM, NY, TX, WI Foreign: CANADA, AUSTRALIA, JAPAN, NETHERLANDS
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1740-2019, Z-1738-2019, Z-1741-2019, Z-1737-2019, Z-1739-2019, Z-1736-2019

Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421060 Phase 3 Femoral Drill Guide Extra Small
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420323 Phase 3 Femoral Drill Guide Large
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421930 System Domed Lateral Femoral Drill Guide Small
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phase 3 Femoral Drill Guide Medium
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420324Phase 3 Femoral Drill Guide Extra Large
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420321 Phase 3 Femoral Drill Guide Small

Terminated Class II Medical devices

Recall started: 1 April 2019
Terminated: 11 May 2020
Reason: Incorrect part description contained on an additional label placed on the packaging: A 14mm length part was incorrectly labeled as being a 12mm length screw
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1845-2019

Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 2

Terminated Class II Medical devices

Recall started: 28 March 2019
Terminated: 2 June 2020
Reason: There is a potential of fracture, bending or shearing of the driver.
Distribution: Worldwide Distribution - US Nationwide in the states: AK, AL, AR, AZ, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC< SD< TN, TX, UT, VA, VT, WA, WI, and WY. The products were distributed to the following foreign countries:
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1302-2019, Z-1303-2019

T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconst
T7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstructi

Terminated Class II Medical devices

Recall started: 1 March 2019
Terminated: 27 May 2020
Reason: Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
Distribution: Worldwide Distribution - US Nationwide Foreign: CHILE CHINA COSTA RICA GUJRAT,INDIA JAPAN MEXICO CDMX SINGAPORE
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1086-2019, Z-1087-2019

Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant
Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant

Terminated Class II Medical devices

Recall started: 28 February 2019
Terminated: 23 April 2020
Reason: Lack of an adequate sterilization validation
Distribution: Nationwide
Initiated: Voluntary: Firm initiated
Recall number: Z-1081-2019

Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989

Terminated Class II Medical devices

Recall started: 21 December 2018
Terminated: 6 May 2020
Reason: The product was potentially being packaged without a taper adapter.
Distribution: US Distribution to states of:: AR, KY, and WA.; Internationally to: Australia and Japan.
Initiated: Voluntary: Firm initiated
Recall number: Z-0972-2019

Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a

Terminated Class II Medical devices

Recall started: 21 December 2018
Terminated: 13 May 2020
Reason: Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
Distribution: MN, VA Foreign: Korea, New Zealand and Japan
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0937-2019, Z-0938-2019

Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766

Terminated Class II Medical devices

Recall started: 28 November 2018
Terminated: 12 May 2020
Reason: There is a potential for silicone shedding during cleaning and sterilization.
Distribution: Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0735-2019, Z-0734-2019

Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospita
Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals

Terminated Class II Medical devices

Recall started: 20 November 2018
Terminated: 14 April 2020
Reason: One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws
Distribution: Country of Japan
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0708-2019, Z-0709-2019

Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion
Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint f

Terminated Class II Medical devices

Recall started: 14 November 2018
Terminated: 12 May 2020
Reason: Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
Distribution: US Distribution to CA, NC, and NY; and International to Germany.
Initiated: Voluntary: Firm initiated
Recall number: Z-1735-2019

Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabil

Terminated Class II Medical devices

Recall started: 31 October 2018
Terminated: 8 April 2019
Reason: Screw is missing from the package
Distribution: Worldwide Distribution: US (nationwide) to states of: OH, FL, NJ, NY, OH, PA, TX, WV and to countries of: CANADA, AUSTRALIA, JAPAN, GERMANY, and NETHERLANDS.
Initiated: Voluntary: Firm initiated
Recall number: Z-0630-2019

NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can

Terminated Class II Medical devices

Recall started: 24 October 2018
Terminated: 14 April 2020
Reason: Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted
Distribution: US Nationwide Distribution in the states of IN, DC, MD
Initiated: Voluntary: Firm initiated
Recall number: Z-0553-2019

Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint rep

Terminated Class II Medical devices

Recall started: 22 October 2018
Terminated: 30 December 2020
Reason: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Distribution: Worldwide - US Nationwide Distribution Foreign: CANADA AUSTRALIA BRAZIL CHILE HONG KONG JAPAN MALAYSIA NETHERLANDS NICARAGUA SINGAPORE TAIWAN
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0533-2019, Z-0532-2019, Z-0537-2019, Z-0534-2019, Z-0539-2019, Z-0541-2019, Z-0531-2019, Z-0542-2019, Z-0536-2019, Z-0540-2019, Z-0530-2019, Z-0538-2019 and 1 more

Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2237-033-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-026-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for im
Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-037-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2490-097-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a pr
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Length Item Number: 47-2490-098-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a pro
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implant
Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implan
and 5 more product lines

Terminated Class II Medical devices

Recall started: 22 October 2018
Terminated: 11 December 2019
Reason: Label on the outer carton or the patient labels does not match label on the inner sterile packaging
Distribution: AR, MO, MN, NJ, NY, OH, MN , NJ, VA
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0495-2019, Z-0496-2019

Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108

Terminated Class II Medical devices

Recall started: 12 October 2018
Terminated: 17 April 2020
Reason: Correction to update the surgical technique for the Compress System. To make users aware of the changes that were made only to the selection criteria section on page 42 regarding which array to use in the placement of the anti-rotation pins.
Distribution: Nationwide Foreign: CANADA ARGENTINA AUSTRALIA BELGIUM CHILE FINLAND JAPAN NETHERLANDS
Initiated: Voluntary: Firm initiated
Recall number: Z-0642-2019

Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Device Anti-Rotation Spindle 178359 Com

Terminated Class II Medical devices

Recall started: 10 October 2018
Terminated: 28 April 2020
Reason: Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.
Distribution: Distributed to accounts in IN, MD, MO, MS, and NM.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0590-2019, Z-0591-2019

Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
Comprehensive Mini Stem, Item No. 113631:

Terminated Class II Medical devices

Recall started: 2 October 2018
Terminated: 2 June 2020
Reason: The set screw is not able to advance or reverse from the original position in the nail.
Distribution: Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and foreign countries of: Chile, Costa Rica, Ecuador and Netherlan
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0452-2019, Z-0453-2019, Z-0449-2019, Z-0450-2019, Z-0448-2019, Z-0451-2019, Z-0447-2019, Z-0454-2019

Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of
Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of
Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fracture
Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures
Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fracture
Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of
Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of
Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of

Terminated Class II Medical devices

Recall started: 21 September 2018
Terminated: 14 April 2020
Reason: There is a potential for comingling of the 43MM and 51 MM molds
Distribution: US Nationwide Distribution in the states of: AZ, FL, MI, OH, VA & WI
Initiated: Voluntary: Firm initiated
Recall number: Z-0399-2019

StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed

Terminated Class II Medical devices

Recall started: 22 August 2018
Terminated: 17 June 2021
Reason: Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Distribution: Worldwide distribution: US Nationwide, Canada Argentina Australia Belgium Brazil Chile Colombia Costa Rica Czech Republic Dominican Republic Ecuador Finland France China Ecuador Germany Greece Hong Kong Indonesia Italy Japan Jordan Korea Lebanon Malaysia Netherland Para
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0396-2019, Z-0397-2019, Z-0398-2019, Z-0394-2019, Z-0393-2019, Z-0395-2019

Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone flap after a craniotomy.
Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment of the bone flap after a craniotomy.
Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1040-12 Used for the re-attachment of the bone flap after a craniotomy.
Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1020-12 Used for the re-attachment of the bone flap after a craniotomy.
Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy.
Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030 Used for the re-attachment of the bone flap after a craniotomy.

Terminated Class II Medical devices

Recall started: 8 August 2018
Terminated: 30 July 2020
Reason: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Distribution: Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products were distributed to the following foreign countries: Chile
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0160-2019, Z-0143-2019, Z-0154-2019, Z-0136-2019, Z-0137-2019, Z-0138-2019, Z-0165-2019, Z-0148-2019, Z-0153-2019, Z-0125-2019, Z-0127-2019, Z-0130-2019 and 36 more

Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 Product Usage: Intended for the fixation of fractures
Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures
Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 Product Usage: Intended for the fixation of fractures
Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 814311440 Product Usage: Intended for the fixation of fractures
Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 814313180 Product Usage: Intended for the fixation of fractures
Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures
Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product Usage: Intended for the fixation of fractures
and 40 more product lines

Terminated Class II Medical devices

Recall started: 3 August 2018
Terminated: 10 April 2020
Reason: Expiration date incorrectly listed on the label
Distribution: AZ CO FL FL GA LA MA MA MO NY SC TX
Initiated: Voluntary: Firm initiated
Recall number: Z-3252-2018

Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.

Terminated Class II Medical devices

Recall started: 2 August 2018
Terminated: 25 April 2019
Reason: The implant only has one bolt in the sterile package but it should have had two.
Distribution: Worldwide Distribution: US (nationwide) to the following US states: AZ, KS, NM, NV, and UT; and to countries of: Australia and Netherlands.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-3250-2018, Z-3249-2018

Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 Intended for use in Total Knee Arthroplasty
Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty

Terminated Class II Medical devices

Recall started: 30 July 2018
Terminated: 24 October 2019
Reason: The item is labeled as an 8.3mm, but it is actually a 12 mm.
Distribution: The product was not distributed in the United States. The product was distributed in the Netherlands.
Initiated: Voluntary: Firm initiated
Recall number: Z-3246-2018

Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Ti

Terminated Class II Medical devices

Recall started: 20 July 2018
Terminated: 4 June 2020
Reason: The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
Distribution: The products were distributed to the following US states: IN, TN. The products were distributed to the following foreign countries: Australia, Chile, Netherlands.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-3177-2018, Z-3176-2018

Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629
Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612

Terminated Class II Medical devices

Recall started: 17 July 2018
Terminated: 2 June 2020
Reason: The set screw is not able to advance or reverse from the original position in the nail.
Distribution: The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign co
Initiated: Voluntary: Firm initiated
Recall numbers: Z-3053-2018, Z-3054-2018, Z-3141-2018, Z-3092-2018, Z-3122-2018, Z-3157-2018, Z-3144-2018, Z-3159-2018, Z-3114-2018, Z-3080-2018, Z-3115-2018, Z-3164-2018 and 117 more

Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 440 mm, Item Number: 814309440
Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 460 mm, Item Number: 814309460
Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 460 mm, Item Number: 814513460
Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 360 mm, Item Number: 814411360
Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 280 mm, Item Number: 814511280
Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm, Item Number: 814611360
Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 400 mm, Item Number: 814515400
Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 400 mm, Item Number: 814611400
and 121 more product lines

Terminated Class II Medical devices

Recall started: 12 July 2018
Terminated: 1 May 2020
Reason: A size 22mm threaded peg was found in the package of a 10mm unit.
Distribution: International Distribution to countries of: Japan and Netherlands.
Initiated: Voluntary: Firm initiated
Recall number: Z-2965-2018

Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh

Terminated Class II Medical devices

Recall started: 22 June 2018
Terminated: 9 October 2019
Reason: The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was undersized, which could potentially lead to mating issues between the devices. This could cause a delay in surgery of less than 30 minutes. There is an option in the surgical technique for performing limb alignment without the alignment tower.
Distribution: Worldwide Distribution - Nationwide distribution and the countries of Japan and Netherlands.
Initiated: Voluntary: Firm initiated
Recall number: Z-2876-2018

Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures

Terminated Class II Medical devices

Recall started: 18 June 2018
Terminated: 26 March 2020
Reason: Product was manufactured from the incorrect material, which shows a potential decrease in the fatigue strength of the connecting bolt that can lead to fracture.
Distribution: AR, AZ, CA, FL, GA, IN, KY, LA, MA, MI, MN, MO, MT, NJ, NY, OH, SC, TX, UT & WI
Initiated: Voluntary: Firm initiated
Recall number: Z-2875-2018

Connecting Bolt, Model 14-442093

Terminated Class II Medical devices

Recall started: 8 June 2018
Terminated: 14 April 2020
Reason: Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.
Distribution: US distribution to CA, GA, IL, MO, NY, and VA.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2820-2018, Z-2821-2018

ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem

Terminated Class II Medical devices

Recall started: 30 May 2018
Terminated: 28 May 2020
Reason: M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
Distribution: Products were distributed solely to Japan.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2368-2018, Z-2364-2018, Z-2362-2018, Z-2370-2018, Z-2372-2018, Z-2363-2018, Z-2367-2018, Z-2369-2018, Z-2374-2018, Z-2371-2018, Z-2375-2018, Z-2366-2018 and 3 more

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 13.5; 00-7713-013-00
Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6; 00-7713-006-00
Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 16.25; 00-7713-016-00
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 20; 00-7713-020-00
Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5; 00-7713-005-00
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 12.5; 00-7713-012-00
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15; 00-7713-015-00
and 7 more product lines

Terminated Class II Medical devices

Recall started: 24 May 2018
Terminated: 7 April 2020
Reason: Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.
Distribution: Distributed to accounts in CA, CT, GA, IA, IN, LA, MA, MD, MN, MS, NJ, OH, PA, TN, TX, UT, VA, WI. Foreign distribution to Taiwan, Japan, and the Netherlands.
Initiated: Voluntary: Firm initiated
Recall number: Z-2289-2018

Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthroplasties.

Terminated Class II Medical devices

Recall started: 18 May 2018
Terminated: 31 March 2020
Reason: One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.
Distribution: US Distribution to the states of : FL, GA, IN, MA, NM, UT, and WI. Foreign distribution to Canada and Mexico
Initiated: Voluntary: Firm initiated
Recall number: Z-2177-2018

Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty

Terminated Class II Medical devices

Recall started: 16 May 2018
Terminated: 5 April 2024
Reason: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
Distribution: Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2237-2018, Z-2238-2018, Z-2242-2018, Z-2233-2018, Z-2241-2018, Z-2234-2018, Z-2231-2018, Z-2239-2018, Z-2230-2018, Z-2232-2018, Z-2235-2018, Z-2240-2018 and 1 more

G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended fo
3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
and 5 more product lines

Terminated Class II Medical devices

Recall started: 11 May 2018
Terminated: 21 November 2019
Reason: The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
Distribution: Worldwide distribution: US (nationwide) to states of: AR, CA, FL, GA, IL, IN, KS, MI, MN, MS, NC, OH, PA, TN, TX, and WV and country of: Canada.
Initiated: Voluntary: Firm initiated
Recall number: Z-2183-2018

Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.

Terminated Class II Medical devices

Recall started: 5 April 2018
Terminated: 12 August 2020
Reason: The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product where the threads of the outer plate component have limited to no engagement with the post component.
Distribution: worldwide Distribution - US Distribution to the states of : CA, FL, MO, NC, SC, TX, and WI., and to the countries of : Argentina, China, Colombia, Germany, Japan, Netherlands, South Africa, Thailand, and Vietnam.
Initiated: Voluntary: Firm initiated
Recall number: Z-1705-2018

Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.

Terminated Class II Medical devices

Recall started: 3 April 2018
Terminated: 2 July 2018
Reason: There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.
Distribution: The product was distributed to the following states: CT, FL, GA, IN, MA, MI, NY, and TX. The product was distributed to the following countries: Malaysia and Netherlands.
Initiated: Voluntary: Firm initiated
Recall number: Z-1522-2018

Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of

Terminated Class II Medical devices

Recall started: 2 April 2018
Terminated: 12 May 2020
Reason: Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
Distribution: Worldwide Distribution: US (nationwide) in states of: AL, AR, FL, GA, IN, KY, LA, MO, MS, OH, OK, TX, and VA; and countries of: Canada, Costa Rica and Chile.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1537-2018, Z-1538-2018

Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of m
Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who need total hip art

Terminated Class II Medical devices

Recall started: 29 March 2018
Terminated: 17 December 2019
Reason: There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.
Distribution: Worldwide Distribution - USA (nationwide) to the states of : AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Australia, South Korea, Malaysia, Netherlands, and Sing
Initiated: Voluntary: Firm initiated
Recall number: Z-1381-2018

Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with dise

Terminated Class II Medical devices

Recall started: 28 March 2018
Terminated: 29 March 2019
Reason: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Distribution: Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1735-2018, Z-1736-2018, Z-1738-2018, Z-1737-2018, Z-1734-2018, Z-1739-2018

Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the ankle/foot and knee.
Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee.
Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the ankle/foot and knee.
Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.
Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.

Terminated Class II Medical devices

Recall started: 26 March 2018
Terminated: 18 November 2020
Reason: Potential failure of sterile packaging seal.
Distribution: US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1474-2018, Z-1466-2018, Z-1476-2018, Z-1471-2018, Z-1472-2018, Z-1470-2018, Z-1473-2018, Z-1467-2018, Z-1475-2018, Z-1465-2018, Z-1469-2018, Z-1468-2018

M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length; Item Number: 00-2255-026-00
Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-2255-008-00
ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00
Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00
Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Length; Diameter; Item Number: 47-2490-097-01
ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01
Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length; Item Number: 47-2490-098-00
and 4 more product lines

Terminated Class II Medical devices

Recall started: 12 March 2018
Terminated: 18 November 2019
Reason: Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant.
Distribution: Worldwide Distribution: US (nationwide) AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and countries of: Australia, Brazil, Canada, Chile, Colombia, El Salvador, Netherlands, Japan,
Initiated: Voluntary: Firm initiated
Recall number: Z-1236-2018

Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-

Terminated Class II Medical devices

Recall started: 1 March 2018
Terminated: 18 July 2019
Reason: Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.
Distribution: Distributed in the following U.S. states: AZ, CA, CT, IN, MD, MI, MN, NJ, NY, OR, WA, and Puerto Rico. Distributed in China and India.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1192-2018, Z-1191-2018

Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-007-40

Terminated Class I Medical devices

Recall started: 19 February 2018
Terminated: 25 August 2020
Reason: Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
Distribution: US Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV ; and country of: Australia.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0286-2019, Z-0287-2019

EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

Terminated Class II Medical devices

Recall started: 6 February 2018
Terminated: 2 April 2019
Reason: The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
Distribution: Worldwide and US of Indiana and country of the Republic of Korea.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1197-2018, Z-1196-2018

AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 27.0 810508285 NAIL TIB DYN 08 X 28.5 810508300 NAIL TIB DYN 08 X 30.0 810508315
AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08X27.0 - STERILE 800508285 NAIL TIB DYN 08X28.5 - STERILE 800508300 NAIL TIB DYN 0

Terminated Class II Medical devices

Recall started: 24 January 2018
Terminated: 9 April 2019
Reason: One lot of humeral stem implants do not include the humeral bushing components.
Distribution: Distributed in China and Taiwan.
Initiated: Voluntary: Firm initiated
Recall number: Z-1239-2018

Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)

Terminated Class II Medical devices

Recall started: 3 January 2018
Terminated: 11 April 2019
Reason: Two lots of hip implants are mislabeled.
Distribution: Distributed in 2 US states: LA and NY. Distributed in Canada, China, Japan, and Switzerland.
Initiated: Voluntary: Firm initiated
Recall number: Z-0939-2018

Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681)

Terminated Class II Medical devices

Recall started: 20 December 2017
Terminated: 22 April 2020
Reason: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.
Distribution: USA (nationwide)
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1230-2018, Z-1228-2018, Z-1225-2018, Z-1235-2018, Z-1232-2018, Z-1231-2018, Z-1234-2018, Z-1226-2018, Z-1227-2018, Z-1233-2018, Z-1229-2018

ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER TROC NAIL 130 DEG X 11MM STER TROC NAIL 135 DEG X 11MM The Trochanteric Nail System is intended to treat stable and unstabl
ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractu
ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE TROCH NAIL 130 DEG. X 13MM ACE TROCH NAIL 135 DEG. X 13MM
ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125 STER L H TROC NAIL 380X9X125 STER L H TROC NAIL 400X9X125 STER L H TROC NAIL 420X9X125 STER L H T
ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 DEG X 13MM STER TROC NAIL 130 DEG X 13MM STER TROC NAIL 135 DEG X 13MM The Trochanteric Nail System is intended to treat stable and uns
ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG STRL TROCH NAIL ST 13X180 135DG STRL The Trochanteric Nail System is intended to treat stable and unstable proximal fractures
ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE ATN LAG SCREW 75MM STERILE ATN LAG SCREW 80MM STERILE ATN LAG SCREW 85MM STERILE ATN LAG SCREW 90MM STE
ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP 10MM STER TROC END CAP 15MM STER TROC END CAP 20MM STER TROC END CAP 25MM The Trochanteric Nail System is intended to treat
and 3 more product lines

Terminated Class II Medical devices

Recall started: 12 December 2017
Terminated: 9 April 2019
Reason: A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.
Distribution: Non-USA Customer
Initiated: Voluntary: Firm initiated
Recall number: Z-1224-2018

PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

Terminated Class II Medical devices

Recall started: 8 December 2017
Terminated: 4 September 2018
Reason: Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.
Distribution: US Nationwide in the states of MN, NJ, CA, TX, ND
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0979-2018, Z-0980-2018

Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty

Terminated Class II Medical devices

Recall started: 7 December 2017
Terminated: 17 April 2020
Reason: One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.
Distribution: Canada.
Initiated: Voluntary: Firm initiated
Recall number: Z-1064-2018

6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/8.0mm Cannulated Screw System is part of a series of cannulated screws ranging from

Terminated Class II Medical devices

Recall started: 29 November 2017
Terminated: 2 April 2020
Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Distribution: Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1016-2018, Z-1023-2018, Z-1040-2018, Z-1042-2018, Z-1043-2018, Z-1032-2018, Z-1056-2018, Z-1055-2018, Z-1014-2018, Z-1041-2018, Z-1044-2018, Z-1029-2018 and 36 more

CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is indicated for patients with severe knee pain and disability
CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/L CR OPTION FEM COMP SIZE E/R CR OPTION FEM COMP SIZE F/L CR OPTION FEM COM
LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMORAL D-R LPS-FLEX OPTION FEMORAL E-L LPS-FLEX OPTION FEMORAL E-R LPS-FLEX OPTION F
CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR-FLEX POR HATCP FEM E-R CR-FLEX POR HATCP FEM F-L CR-FLEX POR HATCP FEM F-R CR-F
LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ LPS-FLEX GSF OPT SZ D-R¿ LPS-FLEX GSF OPT SZ E-L¿ LPS-FLEX GSF OPT SZ E-R¿ LPS-FLEX GSK OPT SZ F-L¿ LPS-FLEX GSF OPT SZ F-R¿ LPS-FLEX GSF
FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM PRC LT M/RT L REG+
and 40 more product lines

Terminated Class II Medical devices

Recall started: 29 November 2017
Terminated: 5 April 2019
Reason: Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.
Distribution: USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI., and Internationally to Japan and Netherlands.
Initiated: Voluntary: Firm initiated
Recall number: Z-1238-2018

Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Model Number: 42-5399-

Terminated Class II Medical devices

Recall started: 25 October 2017
Terminated: 1 May 2020
Reason: The drill guides were manufactured with the incorrect color anodization.
Distribution: Distributed in the following US States: AZ, MO, MT, NJ, NY, OH, TX, and WA. Distributed in Chile and Netherlands.
Initiated: Voluntary: Firm initiated
Recall number: Z-1306-2018

A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403

Terminated Class II Medical devices

Recall started: 25 October 2017
Terminated: 12 May 2020
Reason: It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
Distribution: TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT
Initiated: Voluntary: Firm initiated
Recall number: Z-1009-2018

fastener, fixation, nondegradable, soft tissue

Terminated Class II Medical devices

Recall started: 24 October 2017
Terminated: 3 April 2019
Reason: Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in sizes 8mm, 9mm, 10mm, 12mm, and 14mm. Complaints received indicated that flexion has the potential to feel tight during range-of-motion trialing and that the final trial has the potential to appear looser in extension.
Distribution: US Nationwide Distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1240-2018

Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery

Terminated Class II Medical devices

Recall started: 11 October 2017
Terminated: 7 May 2020
Reason: Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Distribution: US Nationwide Distribution
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1072-2018, Z-1071-2018

TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) r
TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.

Terminated Class II Medical devices

Recall started: 3 October 2017
Terminated: 23 August 2018
Reason: The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.
Distribution: US Distribution to states of: FL, WI, MD, MO, and MI.
Initiated: Voluntary: Firm initiated
Recall number: Z-1011-2018

Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty

Terminated Class II Medical devices

Recall started: 3 October 2017
Terminated: 20 August 2018
Reason: The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting in infection and subsequent complications.
Distribution: Distributed in 31 states: AL, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI and the District of Columbia.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0919-2018, Z-0918-2018

Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040
Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04

Terminated Class II Medical devices

Recall started: 29 September 2017
Terminated: 17 April 2019
Reason: Knee implant components (tibial bearings) are labeled with the incorrect size.
Distribution: Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0674-2018, Z-0673-2018

Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty
Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty

Terminated Class II Medical devices

Recall started: 15 September 2017
Terminated: 20 August 2018
Reason: One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.
Distribution: Outside USA
Initiated: Voluntary: Firm initiated
Recall number: Z-1008-2018

36MM COCR MODULAR HD -6MM

Terminated Class II Medical devices

Recall started: 13 September 2017
Terminated: 21 April 2020
Reason: Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
Distribution: Distribution includes US Nationwide.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0774-2018, Z-0775-2018, Z-0773-2018

14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument
979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt. orthopedic instrument

Terminated Class II Medical devices

Recall started: 11 September 2017
Terminated: 30 August 2018
Reason: Cut resistant surgical glove liners lack sterility assurance.
Distribution: Distributed in 29 states: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, MT, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WV and Washington, DC. Distributed to 1 Veteran's Administration hospital in MO. Distributed in Netherland, Peru, and Switzerland.
Initiated: Voluntary: Firm initiated
Recall number: Z-0609-2018

BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two la

Terminated Class II Medical devices

Recall started: 7 September 2017
Terminated: 23 August 2018
Reason: Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution.
Distribution: Nationally
Initiated: Voluntary: Firm initiated
Recall number: Z-0803-2018

The 2nd Assist Knee Positioner

Terminated Class II Medical devices

Recall started: 28 August 2017
Terminated: 23 August 2018
Reason: Potential for the Persona Partial Knee Impactor Pad to fracture.
Distribution: US Nationwide Distribution in the states of AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI. Distributed internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, Switzerland, UK.
Initiated: Voluntary: Firm initiated
Recall number: Z-0596-2018

Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unico

Terminated Class II Medical devices

Recall started: 25 August 2017
Terminated: 16 August 2018
Reason: The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.
Distribution: US Nationwide Distribution
Initiated: Voluntary: Firm initiated
Recall number: Z-0626-2018

G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedu

Terminated Class II Medical devices

Recall started: 25 August 2017
Terminated: 9 August 2018
Reason: The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
Distribution: US Nationwide Distribution to IN, MO, NY, TX.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0627-2018, Z-0628-2018

AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.

Terminated Class II Medical devices

Recall started: 22 August 2017
Terminated: 12 May 2020
Reason: Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors.
Distribution: Distributed domestically to AK, AL, AR, AZ, CA, CO, FL, ID, IN, KY, MA, MD, ME, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI. Distributed internationally to ARGENTINA, AUSTRALIA, CANADA, COSTA RICA, JAPAN, NETHERLANDS.
Initiated: Voluntary: Firm initiated
Recall number: Z-0818-2018

Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.

Terminated Class II Medical devices

Recall started: 7 August 2017
Terminated: 29 March 2019
Reason: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Distribution: US nationwide distribution. Also Portugal and the Netherlands.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0420-2018, Z-0425-2018, Z-0471-2018, Z-0450-2018, Z-0434-2018, Z-0436-2018, Z-0455-2018, Z-0445-2018, Z-0479-2018, Z-0478-2018, Z-0423-2018, Z-0461-2018 and 53 more

Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM
Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM
Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 400MM
and 57 more product lines

Terminated Class II Medical devices

Recall started: 7 August 2017
Terminated: 23 August 2018
Reason: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
Distribution: Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI, and Puerto Rico; and to countries of: Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, Netherlands, and Singap
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1806-2018, Z-1807-2018, Z-1805-2018, Z-1808-2018

Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.
Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.
Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.
Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.

Terminated Class II Medical devices

Recall started: 1 August 2017
Terminated: 18 March 2020
Reason: The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
Distribution: Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and to countries of: Austria,
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0721-2018, Z-0722-2018

Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302)
Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK (Item No.

Terminated Class II Medical devices

Recall started: 5 July 2017
Terminated: 2 April 2019
Reason: Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion.
Distribution: Distributed domestically to AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI. Distributed internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, United Kingdom.
Initiated: Voluntary: Firm initiated
Recall number: Z-0349-2018

Persona Partial Knee System, Size 8, Finishing Guide

Terminated Class II Medical devices

Recall started: 30 June 2017
Terminated: 13 April 2018
Reason: For soft tissue fixation
Distribution: US in the state of Texas
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0993-2018, Z-0992-2018

JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty
DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty

Terminated Class II Medical devices

Recall started: 29 June 2017
Terminated: 7 March 2018
Reason: Device was distributed with the etching missing from the product.
Distribution: Distributed domestically to MI, MN, ND.
Initiated: Voluntary: Firm initiated
Recall number: Z-0312-2018

PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous ar

Terminated Class II Medical devices

Recall started: 12 June 2017
Terminated: 29 June 2018
Reason: A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture
Distribution: AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WV. Internationally to: Australia, Chile, Cost Rica, Ecuador, Netherlands, Panama & Switzerland
Initiated: Voluntary: Firm initiated
Recall number: Z-0516-2018

DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE

Terminated Class II Medical devices

Recall started: 5 June 2017
Terminated: 6 March 2018
Reason: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
Distribution: Nationwide in US; Internationally Argentina, Netherlands & Canada
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0304-2018, Z-0301-2018, Z-0297-2018, Z-0298-2018, Z-0303-2018, Z-0305-2018, Z-0299-2018, Z-0302-2018, Z-0296-2018, Z-0300-2018

RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817
CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
Lateral Troch Plate Full Crimp - 254mm, model # 350838
COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
OSS CEMENTED IM STEM 12X150, model # 150366
RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828
COMP PRIMARY STEM 8MM MINI, model # 113628
CER BIOLOXD OPTION HD 32MM, model # 650-1056
and 2 more product lines

Terminated Class II Medical devices

Recall started: 5 June 2017
Terminated: 17 April 2019
Reason: The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed.
Distribution: Nationwide within U.S.A and Puerto Rico; International: Australia, Brazil, Canada, China, Germany, India, Japan, Netherlands & Singapore
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0547-2018, Z-0548-2018, Z-0549-2018, Z-0550-2018, Z-0551-2018

M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-025-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial ream
M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-026-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial
Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-008-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also as
Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length, Item Number 47-2490-098-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedulla
Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length, Item Number 47-2490-098-01 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedulla

Terminated Class II Medical devices

Recall started: 1 May 2017
Terminated: 13 July 2020
Reason: Robot arm being sent to the wrong position
Distribution: Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0638-2018, Z-0639-2018

ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.