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Smith & Nephew, Inc. recalls LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usa
Recalled December 17, 2014 · FDA recall Z-0591-2015 · Smith & Nephew
Hazard
The stem taper on this device is undersized; the gauge point is not deep enough. · FDA Class II
Units
23 units
Sold at
Worldwide Distribution: US (nationwide) including states of: MI, MN, MO, OH, PA, IA, and TN; and Internationally to: SWITZERLAND; CANADA, COLOMBIA, GERMANY, Dubai, (UAE), THAILAND; SOUTH AFRICA, SOUTH KOREA; and SINGAPORE.
Description
The stem taper on this device is undersized; the gauge point is not deep enough.
Product
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →