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.
Howmedica Osteonics Corp. recalls SCORPIO U-DOME PATELLA knee replacement components due to potential oxidation in raw materials over 5 years old, which could affect material properties.
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.
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 Trident knee replacement inserts manufactured with raw material over 5 years old may have elevated oxidation levels affecting material properties. This FDA Class II recall applies to Lot Number 29518001.
Howmedica Osteonics recalled Scorpio Total Knee prosthetics with UHMWPE components produced from raw material over 5 years old, which may develop elevated oxidation and affect implant properties.
Howmedica Osteonics Corp. recalls knee replacement devices with UHMWPE components manufactured from raw material over 5 years old due to potential oxidation that may affect material properties.
Howmedica Osteonics has recalled certain SCORPIO U-Dome Patella knee implants due to potential material oxidation in units manufactured with raw material over 5 years old. The oxidation may affect the implant's material properties.
Howmedica Osteonics is recalling PS Lipped Tibial Insert knee replacement components manufactured with aged UHMWPE material that may develop oxidation, potentially affecting device properties and performance.
Howmedica Osteonics is recalling tibial bearing inserts used in knee replacements manufactured from UHMWPE raw material over 5 years old. The material may develop elevated oxidation levels that could impact its structural properties.
Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee implants (Lot Numbers 482LM8, HH43K7) manufactured with aged UHMWPE material. The raw material is over 5 years old and may develop oxidation that could affect the implant's material properties.
Howmedica Osteonics recalled TRIDENT knee replacement poly inserts (Part 620-00-28J, Lot 38059601) due to potential UHMWPE material oxidation in components over 5 years old. Oxidation may affect material properties.
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 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 is recalling SCORPIO TS knee implants made with raw material over 5 years old due to potential oxidation that could degrade the device's mechanical properties.
Howmedica Osteonics Corp. is recalling certain knee replacement devices (product number 6637-0-931, lot 57403601) because raw material used in manufacturing may be over 5 years old, potentially causing elevated oxidation that affects device durability.
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-Flex knee implant inserts manufactured with over-5-year-old UHMWPE material, which may develop elevated oxidation levels that could affect material properties.
P7 knee replacement inserts may contain UHMWPE material over 5 years old that has developed oxidation, potentially degrading the material's properties. Patients should consult their healthcare provider.
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 DURATION Plastic Patella knee replacement implants due to potential oxidation in UHMWPE raw material over 5 years old, which may affect implant durability.
Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement inserts manufactured with aging raw material. The material may develop elevated oxidation that could affect performance.
Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement components due to potential oxidation of raw material. Material degradation could affect implant durability.
Howmedica Osteonics Corp. is recalling certain knee replacement implants made with UHMWPE material over 5 years old that may have oxidized, potentially affecting implant 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.
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.