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. is recalling SCORPIO RECESSED PATELLA knee replacement components manufactured from UHMWPE raw material over 5 years of age, which may develop elevated oxidation affecting material 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 is recalling SCORPIO RECESSED PATELLA knee implant components made from UHMWPE material over 5 years old that may develop elevated oxidation.
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 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.
Howmedica Osteonics Corp. is recalling a knee replacement implant insert due to potential material oxidation. UHMWPE raw material over 5 years old may develop elevated oxidation levels, affecting implant properties.
Howmedica Osteonics recalls SCORPIO TS TIB INSERT knee replacement components manufactured with UHMWPE raw material over 5 years old, which may experience elevated oxidation affecting material properties. No injuries or illnesses have been reported.
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patellas manufactured with raw material over 5 years old, which may have elevated oxidation levels affecting material properties.
Knee replacement tibial inserts from Howmedica may have elevated oxidation if manufactured with raw material over 5 years old, potentially affecting material properties.
Howmedica Osteonics is recalling PS LIPPED TIBIAL INSERT ASSY DURACON knee replacement inserts manufactured with UHMWPE raw material over 5 years old. The aged material may develop elevated oxidation that could impact material properties.
Howmedica Osteonics Corp. is recalling SCORPIO TS TIB knee replacement implants manufactured with aged raw material that may develop oxidation, potentially affecting performance.
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 components due to potential oxidation of the UHMWPE material in units manufactured with raw material over 5 years of age.
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 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 SCORPIO Total Knee replacement components from specific manufacturing batches due to potential oxidation in raw materials over 5 years old. Oxidation can impact the material's properties.
Howmedica Osteonics is recalling PRIMARY REV.TIB.INSERT-DURACON knee replacement inserts manufactured with aging UHMWPE material that has potential for oxidation affecting material properties. Affected lots: 36273601 and 36609701.
Howmedica Osteonics is recalling PS Lipped Tibial Insert Assy knee replacement components manufactured with UHMWPE material older than 5 years due to potential oxidation affecting performance.
Howmedica Osteonics Corp. is recalling a SCORPIO TOTAL KNEE prosthesis component because UHMWPE raw material over 5 years old may have elevated oxidation levels affecting material properties and implant performance. Consumers with this implant should contact their physician for guidance.
Howmedica Osteonics Corp. is recalling specific lots of knee replacement implant components manufactured with aged raw material. The UHMWPE material may experience oxidation that could affect its structural properties.
Howmedica Osteonics recalls SCORPIO U-DOME PATELLA knee components. Older UHMWPE raw material may have elevated oxidation, potentially affecting material properties.
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patella components due to potential oxidation in raw materials over 5 years old. No illnesses have been reported.