medical Class II Updated 2024-02-07

Howmedica Osteonics Corp. recalls HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended

Recalled Product

HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J


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: n/a Lot Numbers: 29518001
View official government recall

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