Warsaw, IN, United States
Biomet, Inc. recalls
31 recalls recorded since 2018, most recently on 1 July 2026. 12 are listed as ongoing. Status and classification are as published by the FDA.
Recalls31
Ongoing (FDA)12
Terminated or completed19
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 July 2026
- Reason
- Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
- Distribution
- Refer to the attached ZFA 2026-00096_Initial Consignee List and ZFA 2026-00096_Initial Distribution History containing the distribution and the identification of the affected consignees.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2868-2026, Z-2867-2026, Z-2870-2026, Z-2871-2026, Z-2869-2026
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
Ongoing Class II Medical devices
- Recall started
- 23 September 2025
- Reason
- There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
- Distribution
- Refer to the attached ZFA 2025-00166_Initial Consignee List and ZFA 2025-00166_Initial Distribution History containing the distribution and the identification of the domestic consignees.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0212-2026
- BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
Ongoing Class II Medical devices
- Recall started
- 9 September 2025
- Reason
- The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2619-2025
- Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
Ongoing Class II Medical devices
- Recall started
- 21 October 2024
- Reason
- Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Singapore, Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0477-2025
- JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
Ongoing Class II Medical devices
- Recall started
- 17 May 2024
- Reason
- 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, NJ, PA, TX, VA and the country of Chile.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2179-2024
- RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
Ongoing Class II Medical devices
- Recall started
- 13 March 2024
- Reason
- Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
- Distribution
- Worldwide distribution - US Nationwide in the state of IN and the countries of Canada, India, Netherlands, and P.R. China.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1607-2024
- Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barri
Ongoing Class II Medical devices
- Recall started
- 2 November 2023
- Reason
- One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
- Distribution
- US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0570-2024, Z-0569-2024
- Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
- Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
Ongoing Class II Medical devices
- Recall started
- 9 October 2023
- Reason
- Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- Distribution
- Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, CANADA, CHILE, JAPAN, NETHERLANDS, NEW ZEALAND.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0387-2024, Z-0386-2024, Z-0380-2024, Z-0388-2024, Z-0374-2024, Z-0375-2024, Z-0379-2024, Z-0372-2024, Z-0370-2024, Z-0381-2024, Z-0371-2024, Z-0384-2024 and 7 more
- Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178568
- Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178566
- Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178556
- Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178570
- Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178408
- Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178410
- Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178554
- Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178404
- and 11 more product lines
Ongoing Class II Medical devices
- Recall started
- 6 February 2023
- Reason
- The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.
- Distribution
- US Distribution to states of: AZ, FL, GA, MI, NE, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1284-2023
- G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
Ongoing Class II Medical devices
- Recall started
- 29 December 2022
- Reason
- Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
- Distribution
- International distribution to the countries of: Argentina, China, Costa Rica, India, Japan, Mexico, Netherlands, Ecuador, Republic of Korea, Singapore, and Thailand. Expanded Recall US states of: FL, IN, MD, OH, PA, WI
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1043-2023, Z-1042-2023
- (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED RECALL: (2) Vanguard Knee System PS Open Box Femoral; Left; 60 mm. Item Number:
- (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vang
Ongoing Class II Medical devices
- Recall started
- 15 December 2022
- Reason
- Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of IN, KY and the countries of Canada, New Zealand, Japan, Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1018-2023
- Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341
Ongoing Class II Medical devices
- Recall started
- 29 November 2022
- Reason
- Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
- Distribution
- US Nationwide distribution in the states of CA, KY, FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1036-2023
- OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602
Terminated Class II Medical devices
- Recall started
- 14 February 2022
- Terminated
- 30 September 2024
- Reason
- Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
- Distribution
- Worldwide: US (28 States AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MS, NC, NE, NM, NY, OH, OK, OR, SC, TX, UT, WA, WY), Australia, Japan, and Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0811-2022, Z-0809-2022, Z-0812-2022, Z-0810-2022
- BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identi
- BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a
- BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS
- BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12-176, DVR CROSSLOCK EXTRA EXTRA LONG PLATE RIGHT]. Devices are packaged
Terminated Class II Medical devices
- Recall started
- 7 January 2022
- Terminated
- 13 April 2023
- Reason
- The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0671-2022, Z-0670-2022, Z-0675-2022, Z-0676-2022, Z-0677-2022, Z-0673-2022, Z-0674-2022, Z-0672-2022
- Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611
- Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
- Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item Number: 113632
- Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633
- Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635
- Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618
- Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631
- Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614
Terminated Class II Medical devices
- Recall started
- 2 June 2021
- Terminated
- 6 July 2022
- Reason
- Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2260-2021, Z-2259-2021, Z-2274-2021, Z-2265-2021, Z-2267-2021, Z-2270-2021, Z-2263-2021, Z-2264-2021, Z-2272-2021, Z-2262-2021, Z-2273-2021, Z-2271-2021 and 5 more
- Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301
- Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
- Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343
- Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314
- Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321
- Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331
- Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311
- Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312
- and 9 more product lines
Terminated Class II Medical devices
- Recall started
- 15 January 2021
- Terminated
- 9 March 2023
- Reason
- Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.
- Distribution
- US Nationwide distribution including in the states of MS, MN, KY, FL, MI, OH, AZ, IL, WI, CA, UT, TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1131-2021
- Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
Terminated Class II Medical devices
- Recall started
- 23 December 2020
- Terminated
- 13 April 2023
- Reason
- The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.
- Distribution
- Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0882-2021
- A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone.
Terminated Class II Medical devices
- Recall started
- 1 December 2020
- Terminated
- 8 July 2022
- Reason
- Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Korea, Japan, Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0723-2021
- Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
Terminated Class II Medical devices
- Recall started
- 25 November 2020
- Terminated
- 8 May 2024
- Reason
- Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
- Distribution
- Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0616-2021, Z-0620-2021, Z-0624-2021, Z-0621-2021, Z-0629-2021, Z-0625-2021, Z-0622-2021, Z-0623-2021, Z-0628-2021, Z-0619-2021, Z-0617-2021, Z-0627-2021 and 4 more
- 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790, 110009794, 110009796, 110009798, 110009800 - Product Usage: Fracture fixationof small bones, small
- Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, non-torque-limiting.
- Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and intended to be implanted with bone cement.
- Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functi
- Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone
- PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fracture fixation of small bones, small bone fragements and long bones.
- M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures.
- OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.
- and 8 more product lines
Terminated Class II Medical devices
- Recall started
- 4 September 2020
- Terminated
- 31 August 2021
- Reason
- Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
- Distribution
- Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0083-2021, Z-0084-2021, Z-0081-2021, Z-0082-2021
- Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
- Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
- Biomet Regenerex Primary Taper Cap Item Number 141269
- Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050
Terminated Class II Medical devices
- Recall started
- 3 September 2020
- Terminated
- 20 December 2022
- Reason
- Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.
- Distribution
- Devices were distributed nationwide throughout the United States and to locations OUS. There has been one unit returned prior to the recall and approximately 14 units that have been previously implanted, leaving 33 units in the field subject to removal.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0097-2021
- (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) Ring
Terminated Class II Medical devices
- Recall started
- 2 September 2020
- Terminated
- 31 December 2020
- Reason
- Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters
- Distribution
- US Nationwide distribution including in the states of CO, MN, OH, WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0093-2021
- Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (gle
Terminated Class II Medical devices
- Recall started
- 14 May 2020
- Terminated
- 8 April 2021
- Reason
- Distributed to the field without having completed design history files or design transfer activities
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2306-2020, Z-2310-2020, Z-2311-2020, Z-2312-2020, Z-2324-2020, Z-2315-2020, Z-2309-2020, Z-2319-2020, Z-2308-2020, Z-2304-2020, Z-2314-2020, Z-2317-2020 and 10 more
- A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal h
- A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process
- A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing
- A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during t
- A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal
- A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal h
- A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal heal
- A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal he
- and 14 more product lines
Terminated Class II Medical devices
- Recall started
- 11 May 2020
- Terminated
- 4 November 2020
- Reason
- The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.
- Distribution
- US Nationwide Distribution in the states of CA, FL, IN, KS, KY, MI, OH, and TX. Foreign distribution to Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2300-2020
- Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503 (10)728890, (01)00880304829503 (10)977300
Terminated Class II Medical devices
- Recall started
- 1 May 2020
- Terminated
- 28 July 2021
- Reason
- Device and tray that houses the device did not pass steam sterilization process validation testing
- Distribution
- Nationwide Foreign: CHINA, AUSTRALIA, CHILE, COSTA RICA , NETHERLANDS, SWITZERLAND
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2363-2020, Z-2362-2020
- Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
- Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
Terminated Class II Medical devices
- Recall started
- 17 April 2020
- Terminated
- 25 June 2021
- Reason
- Potential presence of elevated endotoxin levels that exceed the specification limit
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2148-2020, Z-2154-2020, Z-2156-2020, Z-2151-2020, Z-2155-2020, Z-2147-2020, Z-2149-2020, Z-2144-2020, Z-2150-2020, Z-2152-2020, Z-2145-2020, Z-2146-2020 and 1 more
- Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 154339 Oxford Partial Knee Sys
- Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosthesis
- Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthesis
- Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Beari
- Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D5 US15
- Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
- Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibial Component, 14
- Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral B
- and 5 more product lines
Terminated Class II Medical devices
- Recall started
- 13 March 2020
- Terminated
- 21 July 2021
- Reason
- There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
- Distribution
- Worldwide distribution - US Nationwide distribution including the states of AL, CO, KS, MA, MD, MI, MO, NH, NJ, and PA. The countries of Australia, Canada, India, and Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1750-2020
- Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder jo
Terminated Class II Medical devices
- Recall started
- 26 February 2020
- Terminated
- 29 July 2021
- Reason
- Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Distribution
- Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Miss
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1649-2020, Z-1652-2020, Z-1664-2020, Z-1651-2020, Z-1638-2020, Z-1655-2020, Z-1661-2020, Z-1650-2020, Z-1643-2020, Z-1663-2020, Z-1646-2020, Z-1656-2020 and 21 more
- BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
- BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
- BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
- BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
- BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
- BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
- BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
- BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
- and 25 more product lines
Terminated Class II Medical devices
- Recall started
- 25 February 2020
- Terminated
- 5 August 2020
- Reason
- Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.
- Distribution
- International distribution - country of Netherland.s
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1615-2020
- Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross r
Terminated Class II Medical devices
- Recall started
- 17 February 2020
- Terminated
- 31 May 2022
- Reason
- A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.
- Distribution
- International distribution in the countries of Canada, Japan, Netherlands, South Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1543-2020
- Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder syste
Terminated Class II Medical devices
- Recall started
- 28 February 2018
- Terminated
- 11 August 2020
- Reason
- During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent screw engagement in less than 1% of cases.
- Distribution
- Distribution US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1173-2018
- Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction
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.