Howmedica Osteonics Corp. recalls RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for kne
Recalled Product
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931
Hazard / Issue
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.
Issued by
FDA
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