FDA recall Z-0282-2025

Smith & Nephew Inc · Class II · device

Product

smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; 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.

Distribution

US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada

Key facts

Status
Ongoing
Initiation date
2024-10-02
Report date
2024-11-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0282-2025