FDA (Devices) recall action 93687
The FDA (Devices) publishes a recall like this one as 58 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 58 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
The FDA is recalling SCORPIO U-DOME PATELLA knee replacement components because manufacturing used raw material over 5 years old that may have elevated oxidation levels affecting the implant's material properties.
Howmedica Osteonics is recalling knee replacement implants manufactured with aged UHMWPE raw material that may have elevated oxidation levels, which could degrade the material's mechanical properties.
Howmedica Osteonics Corp. is recalling LARGE PRIMARY REV.TIB.INSERT-DURACON knee implants manufactured with aged UHMWPE material that may have elevated oxidation levels. Affected patients should consult their healthcare provider.
Howmedica Osteonics recalls SCORPIO TS TIB knee replacement inserts (lot TA21X9) manufactured from UHMWPE material over 5 years old due to potential elevated oxidation that could affect material properties. No injuries reported.
Howmedica Osteonics Corp. is recalling LEFT LARGE-PCA knee replacement inserts manufactured with raw material over 5 years old due to potential elevated oxidation levels that could affect material properties.
Howmedica Osteonics Corp. is recalling Scorpio NRG Tibial Bearing Insert Assemblies manufactured with raw material over 5 years old, which may develop elevated oxidation affecting implant durability.
Knee replacement components recalled due to potential oxidation in UHMWPE material that could affect durability. Approximately 76 units distributed in the US with additional international distribution.
Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee replacement implants manufactured with UHMWPE material over 5 years old. The aged material may develop elevated oxidation levels that could affect the implant's performance.
Certain SCORPIO U-DOME PATELLA knee replacement devices may experience material degradation due to aged raw material. The manufacturer is recalling affected units because material oxidation could compromise device durability and performance.
Howmedica Osteonics Corp. is recalling P7 28MM 10 DEGREE +4MM INSERT knee replacement components (Lot 61311701, 62122001) due to potential oxidation in aged UHMWPE material that could affect material properties.
Howmedica Osteonics Corp. is recalling Series II tibial bear inserts used in knee replacements. Raw material over 5 years old may have elevated oxidation levels, potentially affecting material properties.
Howmedica Osteonics is recalling SCORPIO TS TIB knee implant inserts (Part Number 72-4-0510) manufactured with UHMWPE material over 5 years old. The material may have elevated oxidation levels that could affect implant performance.
Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee implant components made from UHMWPE material over 5 years old that may develop elevated oxidation.
Howmedica Osteonics is recalling the DUR PCA MTK REV INS RT knee replacement implant manufactured with UHMWPE material over 5 years old. The material can develop elevated oxidation levels that may degrade its properties.
Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee replacement components due to potential oxidation of the UHMWPE material in units manufactured with raw material over 5 years of age.
Howmedica Osteonics recalls DUR PCA MTK REV INS RT knee replacement implants due to potential oxidation of UHMWPE material that could compromise material properties. Patients should contact their healthcare provider.
Howmedica Osteonics is recalling Scorpio-Flex knee prosthesis inserts due to potential oxidation in UHMWPE raw material over 5 years old, which could impact material properties.
Howmedica Osteonics is recalling knee replacement inserts manufactured with UHMWPE material over 5 years old, which may develop elevated oxidation levels that could affect joint stability.
Howmedica Osteonics is recalling Scorpio-Flex knee implant inserts manufactured with over-5-year-old UHMWPE material, which may develop elevated oxidation levels that could affect material properties.
Howmedica Osteonics Corp. is recalling knee replacement implants manufactured with UHMWPE material over 5 years old. The aged material has potential for elevated oxidation levels, which could affect the implant's material properties.
Howmedica Osteonics is recalling Scorpio NRG Tibial Brg Insert Assembly knee replacement components due to potential oxidation of raw materials over 5 years of age, which could affect material properties.
Howmedica is recalling SCORPIO U-DOME PATELLA knee replacement implants manufactured with UHMWPE material over 5 years old due to potential elevated oxidation levels that could affect material properties.
Howmedica Osteonics is recalling a knee replacement patellar component that may have been manufactured with oxidized raw material. Products using UHMWPE over 5 years old can develop elevated oxidation and degraded material properties.
Howmedica Osteonics Corp. is recalling the Series II Tibial Bear Insert for knee replacement because UHMWPE material over 5 years old may develop elevated oxidation that can affect the component's material properties.
Howmedica Osteonics Corp. is recalling DURATION knee replacement tibial inserts manufactured with raw materials over 5 years old that have developed oxidation. Oxidation can degrade the material's structural properties, affecting implant performance.