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Howmedica Osteonics Corp. recalls SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518
Recalled February 7, 2024 · FDA recall Z-0880-2024 · 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
Units
5 units US
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: 72-4-7518
Manufacturer(s)
Howmedica Osteonics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →