Mahwah, NJ, United States
Howmedica Osteonics Corp. recalls
48 recalls recorded since 2018, most recently on 16 September 2026. 26 are listed as ongoing. Status and classification are as published by the FDA.
Recalls48
Ongoing (FDA)26
Terminated or completed22
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 September 2026
- Reason
- Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
- Distribution
- These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will be identified by the countries impacted. 158 trays have been distributed OUS.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0164-2027, Z-0166-2027, Z-0165-2027, Z-0167-2027
- TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
- Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
- TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.
- TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.
Ongoing Class II Medical devices
- Recall started
- 30 July 2026
- Reason
- Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3206-2026, Z-3199-2026, Z-3201-2026, Z-3196-2026, Z-3204-2026, Z-3197-2026, Z-3200-2026, Z-3205-2026, Z-3202-2026, Z-3203-2026, Z-3198-2026, Z-3195-2026
- SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD C-M071-8-400
- ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL POLY CONSTRAINED INSERT 50MM 69-
- OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORP
- DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500 C-M063-2-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-000 SHOULDER - GLENOID #11 536
- SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BIPOLAR 44MM 6074-4422 Orthopaedic implant components manufactured from
- and 4 more product lines
Ongoing Class II Medical devices
- Recall started
- 19 May 2026
- Reason
- Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
- Distribution
- US Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2461-2026, Z-2462-2026
- TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
- TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
Ongoing Class II Medical devices
- Recall started
- 2 February 2026
- Reason
- A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.
- Distribution
- Domestic: Nationwide Distribution; International: Australia, Germany, Belgium, France, Spain UK, New Zealand;
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1572-2026
- MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
Ongoing Class II Medical devices
- Recall started
- 12 November 2025
- Reason
- When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0963-2026
- The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which inc
Ongoing Class II Medical devices
- Recall started
- 28 August 2025
- Reason
- a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
- Distribution
- International distribution in the country of United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2640-2025
- 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
Ongoing Class II Medical devices
- Recall started
- 4 September 2024
- Reason
- Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.
- Distribution
- US Nationwide distribution in the states of AZ, FL, NC, OH, PA, TN, WI. Stryker issued Urgent Medical Device Recall (UMDR) PFA 3554908 by third party Sedgwick on September 04, 2024, via UPS 2-day air. Letter states reason for recall, health risk and action to take: 1. Please inform users of t
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0023-2025
- Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected fo
Ongoing Class II Medical devices
- Recall started
- 7 August 2024
- Reason
- Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0044-2025
- MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Ongoing Class II Medical devices
- Recall started
- 5 August 2024
- Reason
- A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
- Distribution
- International distribution to the country of Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2732-2024
- Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Ongoing Class II Medical devices
- Recall started
- 19 June 2024
- Reason
- Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2370-2024, Z-2372-2024, Z-2371-2024
- UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043
- UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038
- UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
Ongoing Class II Medical devices
- Recall started
- 23 May 2024
- Reason
- The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, Denmark, Hong Kong, Iran, Italy, Japan, Kuwait, Mexico, New Zealand, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, UK, Venlo.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2153-2024, Z-2152-2024
- Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
- HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Ongoing Class II Medical devices
- Recall started
- 27 February 2024
- Reason
- The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Distribution
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1631-2024, Z-1628-2024, Z-1627-2024, Z-1622-2024, Z-1630-2024, Z-1632-2024, Z-1623-2024, Z-1624-2024, Z-1626-2024, Z-1629-2024, Z-1621-2024, Z-1625-2024
- TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
- TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
- TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
- TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
- TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E
- TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H
- TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
- TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
- and 4 more product lines
Ongoing Class II Medical devices
- Recall started
- 6 February 2024
- Reason
- Potential packaging breaches of inner blister and outer sterile blister.
- Distribution
- Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1264-2024, Z-1260-2024, Z-1259-2024, Z-1263-2024, Z-1262-2024, Z-1261-2024, Z-1266-2024, Z-1265-2024
- NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
- X3 TRIATHLON CS INSERT NO 6 10 MM
- X3 TRIATHLON CS INSERT NO 3 10 MM
- NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
- X3 TRIATHLON CS INSERT NO 7 9 MM
- X3 TRIATHLON CS INSERT NO 6 11 MM
- NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
- NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
Ongoing Class II Medical devices
- Recall started
- 22 December 2023
- Reason
- Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, China (Hong Kong), Columbia, Italy, Japan, Malaysia, Netherlands (Venlo), Slovenia, S. Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0999-2024, Z-1000-2024
- HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
- HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty
Ongoing Class II Medical devices
- Recall started
- 1 December 2023
- Reason
- Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Distribution
- Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0885-2024, Z-0914-2024, Z-0923-2024, Z-0886-2024, Z-0910-2024, Z-0897-2024, Z-0892-2024, Z-0891-2024, Z-0893-2024, Z-0917-2024, Z-0869-2024, Z-0870-2024 and 46 more
- Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
- PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031
- PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411
- SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110
- LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631
- SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
- SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910
- SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710
- and 50 more product lines
Ongoing Class II Medical devices
- Recall started
- 3 May 2023
- Reason
- The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head.
- Distribution
- International distribution in the country of Ireland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1921-2023
- Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
Ongoing Class II Medical devices
- Recall started
- 13 April 2023
- Reason
- Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa
- Distribution
- US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC Foreign: China, Japan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1654-2023, Z-1653-2023
- TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
- TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
Ongoing Class II Medical devices
- Recall started
- 10 March 2023
- Reason
- Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
- Distribution
- U.S., Netherlands, Japan, China, India, Korea, and Australia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1386-2023, Z-1385-2023
- stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
- stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
Ongoing Class III Medical devices
- Recall started
- 7 November 2022
- Reason
- Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.
- Distribution
- International distribution in the country of Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0736-2023, Z-0737-2023
- Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
- Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
Ongoing Class II Medical devices
- Recall started
- 21 October 2022
- Reason
- Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010)
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0240-2023
- Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
Ongoing Class II Medical devices
- Recall started
- 24 August 2022
- Reason
- A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing.
- Distribution
- Distributed to one customer located in New York.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1778-2022
- Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
Ongoing Class II Medical devices
- Recall started
- 30 March 2022
- Reason
- Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.
- Distribution
- Worldwide distribution - US Nationwide in the states of AL, CA, CO, ID, IN, KS, MI, NV, PA, TN, WA, and WV. The countries of UK and Poland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1237-2022
- Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
Ongoing Class II Medical devices
- Recall started
- 14 January 2022
- Reason
- Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, MD, MN, NC, NJ, NY, OH, OR, PA, TN, TX and the countries of Canada, China, Japan, Spain, UK, Netherlands, Germany & Belgium. ***Updated 3/17/22: U.S., Canada, China, Japan, UK, and Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0843-2022, Z-0842-2022
- Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
- Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
Terminated Class II Medical devices
- Recall started
- 30 December 2021
- Terminated
- 14 March 2024
- Reason
- There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
- Distribution
- The product was distributed to the following US states: MI
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0652-2022, Z-0651-2022
- Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440
- Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044
Ongoing Class II Medical devices
- Recall started
- 21 December 2021
- Reason
- There is a potential for the outer Tyvek lid to de-bond from the sealed package.
- Distribution
- Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0644-2022, Z-0645-2022
- 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
- Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
Ongoing Class II Medical devices
- Recall started
- 24 November 2021
- Reason
- Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation
- Distribution
- US Nationwide distribution in the states of GA, MI, NC, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0459-2022
- Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System fo
Ongoing Class II Medical devices
- Recall started
- 15 October 2021
- Reason
- There is a potential for the outer white Tyvek lid to debond from the sealed package.
- Distribution
- Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0314-2022, Z-0313-2022
- 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
- 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
Terminated Class II Medical devices
- Recall started
- 1 July 2021
- Terminated
- 17 May 2023
- Reason
- The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states AR, CO, MN, MS, NJ, OK, PA, TX and the countries of China and Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2329-2021
- Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
Terminated Class II Medical devices
- Recall started
- 5 March 2021
- Terminated
- 10 May 2024
- Reason
- The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Trial Cutting Guide packaging during transport or during impaction of the instrument in surgery.
- Distribution
- Distribution in US to: CA,, GA, NC, NJ, NV, OK, TX, and to Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1379-2021
- Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer. Catalog Number: I-K3834CG0
Terminated Class II Medical devices
- Recall started
- 10 February 2021
- Terminated
- 30 May 2023
- Reason
- Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate.
- Distribution
- Domestic: AZ, GA, MA, MI, MN, NH, NJ, OR, PA, SC, UT, WA, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1186-2021
- Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
Terminated Class II Medical devices
- Recall started
- 16 April 2020
- Terminated
- 15 November 2021
- Reason
- The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- Distribution
- Worldwide distribution including the following states: New York, Arkansas, Oklahoma, Michigan, Delaware, Texas, Louisiana, California, Florida, Arizona, Nevada, Ohio, Colorado, Rhode Island, Iowa, Pennsylvania, Massachusetts, North Carolina, Alabama, New Hampshire, Illinois, New Jersey, Virginia, Ut
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2085-2020, Z-2094-2020, Z-2088-2020, Z-2084-2020, Z-2091-2020, Z-2093-2020, Z-2090-2020, Z-2086-2020, Z-2092-2020, Z-2096-2020, Z-2087-2020, Z-2089-2020 and 4 more
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(17)
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17)
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17)
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17)
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17)
- and 8 more product lines
Terminated Class II Medical devices
- Recall started
- 1 April 2020
- Terminated
- 27 August 2020
- Reason
- Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.
- Distribution
- US distribution to California Colorado Florida Georgia Illinois Indiana Kansas Michigan Ohio Pennsylvania Texas Utah Virginia Washington Wisconsin
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1900-2020
- Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
Terminated Class II Medical devices
- Recall started
- 7 November 2019
- Terminated
- 31 August 2020
- Reason
- May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire
- Distribution
- CA, FL, GA , IA, MA, MI, NC, OH, WI Foreign: Canada, Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0811-2020
- Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254
Terminated Class II Medical devices
- Recall started
- 3 October 2019
- Terminated
- 21 April 2022
- Reason
- Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)
- Distribution
- Foreign: Australia, France, Finland, Germany, Italy, Japan, New Zealand, Netherlands, Norway, Romania, Spain, Sweden and UK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0514-2020
- Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
Terminated Class II Medical devices
- Recall started
- 19 August 2019
- Terminated
- 6 May 2020
- Reason
- Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
- Distribution
- Worldwide distribution - US Nationwide distribution including the states of AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and countries of Argentina,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2760-2019, Z-2759-2019, Z-2757-2019, Z-2758-2019
- TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) an
- TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Compo
- TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and
- TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) an
Terminated Class II Medical devices
- Recall started
- 18 June 2019
- Terminated
- 22 May 2020
- Reason
- Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.
- Distribution
- US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2160-2019
- Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
Terminated Class II Medical devices
- Recall started
- 28 November 2018
- Terminated
- 28 May 2020
- Reason
- The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0605-2019
- Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
Terminated Class II Medical devices
- Recall started
- 26 November 2018
- Terminated
- 26 May 2020
- Reason
- Instead of having a spherical diameter, the probe was observed to have 2 radii and a flat surface. Additionally, upon further investigation, it was observed that some parts exhibited an edge on the intersection between the radius and the diameter of the probe.
- Distribution
- Worldwide distribution: US Distribution to the state of: PA and countries of:: Australia, Canada, France, Italy, Netherlands, Poland, and Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0657-2019
- Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as
Terminated Class II Medical devices
- Recall started
- 15 November 2018
- Terminated
- 18 June 2020
- Reason
- Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19
- Distribution
- CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0677-2019, Z-0678-2019
- HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
- HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE
Terminated Class II Medical devices
- Recall started
- 12 September 2018
- Terminated
- 16 July 2020
- Reason
- The firm received complaints related to the locking mechanism on the steerable inserter not functioning as intended. The firm confirmed that the issue is related to lack of lubrication of the instrument. There are two potential hazards associated with the implant pivoting unexpectedly during implant insertion into the disc space. First, if the implant is initially inserted into the disc space via the impaction method and the implant pivots unexpectedly, the implant potentially may unintentionally contact sensitive anatomy. Additionally, the user may potentially experience difficulty positioning the implant within the disc space due to the lack of rigidity. A third potential hazard is associated with the inserter not unlocking at the articulating pivot head during implant positioning within the disc space. Once the implant is in the prepared disc space and contacts the ventral annulus, the surgeon unlocks the articulating pivot head and positions the implant perpendicular to the spinous process. The surgeon may then elect to lock/unlock the articulating pivot head for desired final positioning of the implant. If the inserter does not unlock during these final implant positioning steps, the user may potentially implant the cage in a suboptimal trajectory/placement.
- Distribution
- US Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0207-2019
- Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter
Terminated Class II Medical devices
- Recall started
- 10 September 2018
- Terminated
- 31 August 2020
- Reason
- Potential for outer pouch sterile barrier to be compromised
- Distribution
- US Nationwide in the states of AL, FL, IL, MI, NJ & OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0373-2019
- Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual
Terminated Class II Medical devices
- Recall started
- 22 May 2018
- Terminated
- 8 May 2020
- Reason
- The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
- Distribution
- Distributed nationwide. Foreign distribution to Australia, Canada, Chile, China, Brazil, France, Germany, India, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Portugal, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2293-2018, Z-2292-2018, Z-2294-2018, Z-2298-2018, Z-2297-2018, Z-2296-2018, Z-2299-2018, Z-2295-2018
- LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040
- LFIT Anatomic CoCr Femoral Heads, 6260-9-036
- LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-044
- LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336
- LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-144
- LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-140
- LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236
- LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-136
Terminated Class II Medical devices
- Recall started
- 30 January 2018
- Terminated
- 7 May 2020
- Reason
- Customers may receive the incorrect size implant from what is labeled on the box.
- Distribution
- USA (nationwide) Distribution to the states of : AL, AZ, CA, FL, GA, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1462-2018
- Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.
Terminated Class II Medical devices
- Recall started
- 12 January 2018
- Terminated
- 7 May 2020
- Reason
- Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
- Distribution
- Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1512-2018
- Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Terminated Class II Medical devices
- Recall started
- 21 December 2017
- Terminated
- 5 October 2018
- Reason
- From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to the locking screw.
- Distribution
- NY, FL, KS
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2567-2018
- Custom Made Implant System with Minimum Invasive Grower (MIG) component
Terminated Class II Medical devices
- Recall started
- 24 October 2017
- Terminated
- 18 May 2023
- Reason
- Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Distribution
- Distribution US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2729-2018, Z-2694-2018, Z-2676-2018, Z-2715-2018, Z-2713-2018, Z-2668-2018, Z-2674-2018, Z-2688-2018, Z-2725-2018, Z-2675-2018, Z-2672-2018, Z-2716-2018 and 58 more
- radial stem implant #3 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
- Radio Capitellum Small, Left. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
- Lateral Assembly, Radial Head Impl Assembly, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
- rHead Recon Stem Implant non-coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
- #4 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
- Lat Assembly, Rad Stem Implant,Collar 6mm,Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
- Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
- rHead Recon Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
- and 62 more product lines
Terminated Class II Medical devices
- Recall started
- 8 September 2017
- Terminated
- 31 July 2018
- Reason
- When the lever of the Insertion Handle is in the "locked" position, the implant may be able to pivot rather than maintaining a rigid connection.
- Distribution
- Nationally
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0810-2018
- AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement between the two compo
Terminated Class II Medical devices
- Recall started
- 21 July 2017
- Terminated
- 12 March 2020
- Reason
- Inner and outer sterile barriers not fully sealed.
- Distribution
- Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0940-2018, Z-0941-2018
- Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
- Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
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.