medical Class II Updated 2024-02-07

Howmedica Osteonics Corp. recalls TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for kn

Recalled Product

TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324


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: 04546540117144 Lot Numbers: 59065701
View official government recall

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