Howmedica Osteonics Corp. recalls PRIMARY REV.TIB.INSERT-DURACON Intended for knee replac
Recalled Product
PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031
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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