February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
Hazard: 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.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032
Hazard: 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.