PlainRecalls
FDA Devices Moderate Class II Ongoing

smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic

Reported: November 6, 2024 Initiated: October 2, 2024 #Z-0281-2025

Product Description

smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic

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.

Details

Recalling Firm
Smith & Nephew Inc
Units Affected
5 units
Distribution
US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic. Recalled by Smith & Nephew Inc. Units affected: 5 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 6, 2024. Severity: Moderate. Recall number: Z-0281-2025.