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Smith & Nephew, Inc. recalls LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5
Recalled June 30, 2021 · FDA recall Z-1951-2021 · Smith & Nephew
Hazard
The device components experienced a manufacturing process error that resulted in surface damage from product handling. · FDA Class II
Units
5 units
Sold at
US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.
Description
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
Product
LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →