medical Class II Updated 2024-02-07

Howmedica Osteonics Corp. recalls LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee

Recalled Product

LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231


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

Distribution: Nationwide (United States)
Lot/Code Info: GTIN: 04546540306029 Lot Numbers: 42787901
View official government recall

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