medical Class II Updated 2024-02-07

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

Recalled Product

LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631


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: 04546540306203 Lot Numbers: 36272501,42380501 42771601
View official government recall

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