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Howmedica Osteonics Recalls
232 recalls on record · September 21, 2016 to June 24, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 13, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls X3 TRIATHLON CS INSERT NO 6 11 MM
Hazard: Potential packaging breaches of inner blister and outer sterile blister.
March 13, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls X3 TRIATHLON CS INSERT NO 6 10 MM
Hazard: Potential packaging breaches of inner blister and outer sterile blister.
March 13, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls X3 TRIATHLON CS INSERT NO 3 10 MM
Hazard: Potential packaging breaches of inner blister and outer sterile blister.
February 14, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip
Hazard: 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
February 14, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip art
Hazard: 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
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324
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 PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416
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 PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413
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 PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411
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 DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
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 DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709
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 DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
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 DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609
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 DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
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 DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
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 DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
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 LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231
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 PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031
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 RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931
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 RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
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 RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831
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 LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631
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 LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328
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 LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231
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 LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228
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 LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028
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 P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307
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 P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107
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 HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
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 HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
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.