FDA-Device2013-11-13Class II

GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic

Smith & Nephew Inc
Hazard

Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

Sold states
USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.
Affected count
4 units
Manufactured in
1450 E. Brooks Rd, N/A, Memphis, TN, United States
Products
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0130-2014

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