FDA-Device2014-12-17Class II
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Smith & Nephew, Inc.
Hazard
The stem taper on this device is undersized; the gauge point is not deep enough.
Sold states
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.
Affected count
24 units
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0589-2015Don't want to check this manually?
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