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Howmedica Osteonics Corp. recalls SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
Recalled February 7, 2024 · FDA recall Z-0875-2024 · 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
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
Manufacturer(s)
Howmedica Osteonics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →