Howmedica Osteonics recalls
28 official recalls and safety alerts involving Howmedica Osteonics since 2021-12, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Howmedica Osteonics or the relevant agency.
- 2026-09-23
USHowmedica Osteonics Corp. recalls 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…
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…
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Canada, LATAM,…Official notice →- 2026-06-24
- US
Howmedica Osteonics Corp. recalls TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
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…
FDA · DeviceHowmedica Osteonics Corp.US Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV.Official notice → - 2026-03-25
- US
Howmedica Osteonics Corp. recalls MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
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…
FDA · DeviceHowmedica Osteonics Corp.Domestic: Nationwide Distribution; International: Australia, Germany, Belgium,…Official notice → - 2025-12-31
- US
Howmedica Osteonics Corp. recalls The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR)…
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.
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Canada, Germany,…Official notice → - 2025-10-08
- US
Howmedica Osteonics Corp. recalls 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;
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.
FDA · DeviceHowmedica Osteonics Corp.International distribution in the country of United Kingdom.Official notice → - 2024-10-16
- US
Howmedica Osteonics Corp. recalls MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Australia, Germany.Official notice → - US
Howmedica Osteonics Corp. recalls Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and…
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.
FDA · DeviceHowmedica Osteonics Corp.US Nationwide distribution in the states of AZ, FL, NC, OH, PA, TN, WI.…Official notice → - 2024-09-04
- US
Howmedica Osteonics Corp. recalls Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
FDA · DeviceHowmedica Osteonics Corp.International distribution to the country of Australia.Official notice → - 2024-07-24
- US
Howmedica Osteonics Corp. recalls UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043
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…
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Australia, Hong…Official notice → - 2024-06-26
- US
Howmedica Osteonics Corp. recalls Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
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…
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2024-05-01
- US
Howmedica Osteonics Corp. recalls TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
FDA · DeviceHowmedica Osteonics Corp.Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UKOfficial notice → - 2024-03-13
- US
Howmedica Osteonics Corp. recalls NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Potential packaging breaches of inner blister and outer sterile blister.
FDA · DeviceHowmedica Osteonics Corp.Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile,…Official notice → - 2024-02-14
- US
Howmedica Osteonics Corp. recalls HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
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
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2024-02-07
- US
Howmedica Osteonics Corp. recalls Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
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.
FDA · DeviceHowmedica Osteonics Corp.Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China,…Official notice → - 2023-06-21
- US
Howmedica Osteonics Corp. recalls Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
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.
FDA · DeviceHowmedica Osteonics Corp.International distribution in the country of Ireland.Official notice → - 2023-06-07
- US
Howmedica Osteonics Corp. recalls TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
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
FDA · DeviceHowmedica Osteonics Corp.US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC…Official notice → - 2023-04-19
- US
Howmedica Osteonics Corp. recalls stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
FDA · DeviceHowmedica Osteonics Corp.U.S., Netherlands, Japan, China, India, Korea, and Australia.Official notice → - US
Howmedica Osteonics Corp. recalls stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
FDA · DeviceHowmedica Osteonics Corp.U.S., Netherlands, Japan, China, India, Korea, and Australia.Official notice → - 2022-12-28
- US
Howmedica Osteonics Corp. recalls Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:…
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.
FDA · DeviceHowmedica Osteonics Corp.International distribution in the country of Turkey.Official notice → - 2022-11-23
- US
Howmedica Osteonics Corp. recalls Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
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)
- 2022-10-05
- US
Howmedica Osteonics Corp. recalls Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
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…
FDA · DeviceHowmedica Osteonics Corp.Distributed to one customer located in New York.Official notice → - 2022-06-15
- US
Howmedica Osteonics Corp. recalls Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog…
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.
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide in the states of AL, CA, CO, ID, IN,…Official notice → - 2022-04-06
- US
Howmedica Osteonics Corp. recalls Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
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
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - 2022-02-23
- US
Howmedica Osteonics Corp. recalls Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
FDA · DeviceHowmedica Osteonics Corp.The product was distributed to the following US states: MIOfficial notice → - US
Howmedica Osteonics Corp. recalls 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
There is a potential for the outer Tyvek lid to de-bond from the sealed package.
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Puerto Rico and the countries of Canada, and…Official notice → - 2022-01-12
- US
Howmedica Osteonics Corp. recalls Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of…
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…
FDA · DeviceHowmedica Osteonics Corp.US Nationwide distribution in the states of GA, MI, NC, TX.Official notice → - 2021-12-08
- US
Howmedica Osteonics Corp. recalls 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
There is a potential for the outer white Tyvek lid to debond from the sealed package.
- US