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Howmedica Osteonics Corp. recalls DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
Recalled February 7, 2024 · FDA recall Z-0920-2024 · Howmedica Osteonics
Hazard
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. · FDA Class II
Sold at
Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
Description
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.
Product
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
Manufacturer(s)
Howmedica Osteonics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →