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Sign in to claim this brandHowmedica Osteonics Corp.
United States·US-MF-000001881
Last updated September 18, 2026
What Howmedica Osteonics Corp. makes
The company manufactures reusable orthopaedic instruments for positioning implants during knee and hip surgeries, including tibial and femoral trial components for knee prostheses. It also produces acetabular liners—both non-constrained and constrained polyethylene—and prefabricated acetabular trial components for hip replacements, as well as reusable tibial inserts for knee implants.
These devices are classified under FDA regulations as Class I, Class II, and Class III, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Howmedica Osteonics Corp. manufacture?
Howmedica Osteonics Corp. specializes in reusable orthopaedic instruments and components used during knee and hip surgeries. Their products include positioning instruments for implant placement, tibial and femoral trial components for knee prostheses, acetabular liners (both non-constrained and constrained polyethylene), prefabricated acetabular trial components for hip replacements, and tibial inserts for knee implants. These devices are designed to assist surgeons in achieving precise implant alignment and fit.
Where is Howmedica Osteonics Corp. based?
Howmedica Osteonics Corp. is headquartered in the United States. The company’s location in the US aligns with regulatory frameworks governing medical device manufacturing, distribution, and compliance in North America.
Which regulatory registries list devices manufactured by Howmedica Osteonics Corp?
Devices produced by Howmedica Osteonics Corp. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for each device’s identification, classification, and regulatory status under FDA guidelines.
How are the devices manufactured by Howmedica Osteonics Corp. classified under FDA regulations?
The devices produced by Howmedica Osteonics Corp. fall under three FDA device classes: Class I (generally low-risk devices), Class II (devices requiring special controls to ensure safety and effectiveness), and Class III (high-risk devices requiring premarket approval). The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, such as orthopaedic implants or surgical instruments.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 325, Corporate Drive , Mahwah, United States
- Website
- www.stryker.com
- —
- —
- [email protected]
- Phone
- 201-831-5000
- PRRC Contact
- Dervillia Murphy
- EUDAMED SRN
- US-MF-000001881
- FDA FEI Number
- —
- DUNS Number
- 058311945
Catalogue (16216)
Page 8 of 325| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Instrument | 2102-0458 | FDA UDI | Class II | Active |
| Trident | 623-00-40J | FDA UDI | Class II | Active |
| Instrument | I-K3982FE13 | FDA UDI | Class II | Active |
| Instrument | 6633-2-116 | FDA UDI | Class I | Active |
| Instrument | 5537-T-411X | FDA UDI | Class I | Active |
| Trident X3 Insert | 763-00-28H | FDA UDI | Class II | Active |
| Omnifit | 2041C-3258 | FDA UDI | Class II | Active |
| Instrument | I-K0480PC06 | FDA UDI | Class I | Active |
| Instrument | I-K1757KF13 | FDA UDI | Class I | Active |
| Instrument | 5538-T-313 | FDA UDI | Class II | Active |
| Instrument | T75-5-0705L | FDA UDI | Class I | Active |
| Trident | 641-00-28H | FDA UDI | Class II | Active |
| Duracon | 6642-5-413 | FDA UDI | Class II | Active |
| Instrument | 5532-T-613Y | FDA UDI | Class II | Active |
| Instrument | 5532-T-613A | FDA UDI | Class II | Active |
| Triathlon | 5530-G-111 | FDA UDI | Class II | Active |
| Scorpio | 72-12-0918 | FDA UDI | Class II | Active |
| Restoration | 6528-0612 | FDA UDI | Class II | Active |
| Anato | 4845-7-218 | FDA UDI | Class II | Active |
| Duracon | 6637-0-813 | FDA UDI | Class II | Active |
| Instrument | 6278-9-220 | FDA UDI | Class I | Active |
| Instrument | 2208-4066 | FDA UDI | Class II | Active |
| Instrument | 6543-6-518 | FDA UDI | Class I | Active |
| Instrument | 6496-9-967 | FDA UDI | Class I | Active |
| Gmrs | 6495-5-115 | FDA UDI | Class II | Active |
| Trident | 643-00-32J | FDA UDI | Class II | Active |
| Instrument | I-H1511HF50 | FDA UDI | Class I | Active |
| Instrument | 5530-T-319Y | FDA UDI | Class II | Active |
| Instrument | 2107-4040 | FDA UDI | Class II | Active |
| Trident | 690-10-28J | FDA UDI | Class II | Active |
| Omniflex | 1022-0014 | FDA UDI | Class II | Active |
| Instrument | I-K1922TS29 | FDA UDI | Class I | Active |
| Mrh | 6481-1-200 | FDA UDI | Class II | Active |
| Omnifit | S-2302C-2870 | FDA UDI | Class II | Active |
| Instrument | I-H21103650 | FDA UDI | Class II | Active |
| Instrument | 6278-3-160 | FDA UDI | Class I | Active |
| Instrument | 1440-1400 | FDA UDI | Class II | Active |
| Triathlon | 5531-P-119 | FDA UDI | Class II | Active |
| C-Taper Head | 06-2210 | FDA UDI | Class II | Active |
| Instrument | 5512-T-301 | FDA UDI | Class II | Active |
| System 12 | 6302-5-095 | FDA UDI | Class II | Active |
| Instrument | 6541-2-606Y | FDA UDI | Class II | Active |
| V40 Head | 6260-9-032 | FDA UDI | Class II | Active |
| V40 Head | 6260-9-332 | FDA UDI | Class II | Active |
| Instrument | 6430-1-009 | FDA UDI | Class I | Active |
| Instrument | 2210-28C | FDA UDI | Class II | Active |
| Triathlon | 5531-G-709 | FDA UDI | Class II | Active |
| Morse Head | S-1399-HH31 | FDA UDI | Class II | Active |
| Scorpio | 82-7-0310 | FDA UDI | Class II | Active |
| Trident | 500-01-52E | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
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FDA Recalls (100)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Howmedica Osteonics Corp. has 233 recall records spanning from November 12, 2002, to February 2, 2026, with statuses recorded as open, classified, or terminated. The recalls involve issues such as software error messages preventing device activation, mismatched custom-made devices, potential product mix-ups in labeling, incorrect expiry dates, distortion from repeated autoclaving, oversized internal profiles in certain components, detachment risks in packaging, loosening screws, overhanging device parts, and mechanical failures like locking mechanism malfunctions or fractured components. Reasons include manufacturing defects, labeling errors, and design or material-related concerns.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 2, 2026 | Z-1572-2026 | — | open, classified | 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. |
| Nov 12, 2025 | Z-0963-2026 | — | open, classified | 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. |
| Aug 28, 2025 | Z-2640-2025 | — | open, classified | 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. |
| Sep 4, 2024 | Z-0023-2025 | — | open, classified | 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. |
| Aug 7, 2024 | Z-0044-2025 | — | open, classified | Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces. |
| Aug 5, 2024 | Z-2732-2024 | — | open, classified | A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal. |
| Jun 19, 2024 | Z-2372-2024 | — | open, classified | 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) |
| Jun 19, 2024 | Z-2370-2024 | — | open, classified | 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) |
| Jun 19, 2024 | Z-2371-2024 | — | open, classified | 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) |
| May 23, 2024 | Z-2153-2024 | — | open, classified | 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. |
| May 23, 2024 | Z-2152-2024 | — | open, classified | 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. |
| Feb 27, 2024 | Z-1624-2024 | — | open, classified | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Z-1628-2024 | — | open, classified | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Z-1621-2024 | — | open, classified | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Z-1627-2024 | — | open, classified | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Z-1623-2024 | — | open, classified | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Z-1622-2024 | — | open, classified | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Z-1629-2024 | — | open, classified | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Z-1631-2024 | — | open, classified | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Z-1632-2024 | — | open, classified | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Z-1626-2024 | — | open, classified | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Z-1625-2024 | — | open, classified | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 27, 2024 | Z-1630-2024 | — | open, classified | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Feb 6, 2024 | Z-1261-2024 | — | open, classified | Potential packaging breaches of inner blister and outer sterile blister. |
| Feb 6, 2024 | Z-1260-2024 | — | open, classified | Potential packaging breaches of inner blister and outer sterile blister. |
| Feb 6, 2024 | Z-1259-2024 | — | open, classified | Potential packaging breaches of inner blister and outer sterile blister. |
| Feb 6, 2024 | Z-1263-2024 | — | open, classified | Potential packaging breaches of inner blister and outer sterile blister. |
| Feb 6, 2024 | Z-1262-2024 | — | open, classified | Potential packaging breaches of inner blister and outer sterile blister. |
| Feb 6, 2024 | Z-1265-2024 | — | open, classified | Potential packaging breaches of inner blister and outer sterile blister. |
| Feb 6, 2024 | Z-1264-2024 | — | open, classified | Potential packaging breaches of inner blister and outer sterile blister. |
| Feb 6, 2024 | Z-1266-2024 | — | open, classified | Potential packaging breaches of inner blister and outer sterile blister. |
| Dec 22, 2023 | Z-1000-2024 | — | open, classified | 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 |
| Dec 22, 2023 | Z-0999-2024 | — | open, classified | 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 |
| Dec 1, 2023 | Z-0918-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0883-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0878-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0906-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0896-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0917-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0884-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0919-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0879-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0904-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0892-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0887-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0869-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0910-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0893-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0905-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0922-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0886-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0907-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0900-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0873-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0874-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0871-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0902-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0881-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0901-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0875-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0913-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0877-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0916-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0921-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0903-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0898-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0889-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0894-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0912-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0897-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0915-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0891-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0890-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0885-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0924-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0899-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0908-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0909-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0895-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0911-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0888-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0926-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0876-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0914-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0923-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0882-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0870-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0880-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0872-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0925-2024 | — | open, classified | 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. |
| Dec 1, 2023 | Z-0920-2024 | — | open, classified | 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. |
| May 3, 2023 | Z-1921-2023 | — | open, classified | 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. |
| Apr 13, 2023 | Z-1653-2023 | — | open, classified | 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 |
| Apr 13, 2023 | Z-1654-2023 | — | open, classified | 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 |
| Mar 10, 2023 | Z-1386-2023 | — | open, classified | Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking |
| Mar 10, 2023 | Z-1385-2023 | — | open, classified | Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking |
| Nov 7, 2022 | Z-0737-2023 | — | open, classified | 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. |
| Nov 7, 2022 | Z-0736-2023 | — | open, classified | 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. |
| Oct 21, 2022 | Z-0240-2023 | — | open, classified | 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) |
| Aug 24, 2022 | Z-1778-2022 | — | open, classified | 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. |