Class II
Medical Device Recall: smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
Smith & Nephew Inc · October 2, 2024
Reason for Recall
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.
Distribution
US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada
States Affected
AL, CA, DE, GA, MS, NC, TN
Quantity Affected
5 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0281-2025
Status: ongoing
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