Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIHOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIHOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIScorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIScorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIScorpio-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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIScorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IIScorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
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.
- 2024-02-07FDA-DeviceHowmedica Osteonics Corp.Class IISERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
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.
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