DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711 — recall Z-0922-2024
U.S. FDA — Device Enforcement · United States · 2023-12-01 · Class II
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Reported risk: 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.
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