Howmedica Osteonics Corp.: SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 143 units US; 290 units OUS Lot/code info: GTIN: 07613327033915 Lot Numbers: 73JP, V17W, N2MY, PK0D, D3M3, LEAY, 4NTR,R5WA, JN8M, 084W, K6YE, 84A4, XREK, YNM1, LY5M, M1AT, 4873

UPC codes

07613327033915

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.