FDA-Device2024-11-06Class II
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
Smith & Nephew Inc
Hazard
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
Sold states
US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada
Affected count
5 units
Manufactured in
6409 E Holmes Rd, N/A, Memphis, TN, United States
Products
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0281-2025Don't want to check this manually?
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