medical Class II Updated 2024-02-07

Howmedica Osteonics Corp. recalls DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee

Recalled Product

DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911


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:04546540318299 Lot Numbers: 56000801, 57491601
View official government recall

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