FDA recall Z-0277-2025

Smith & Nephew Inc · Class II · device

Product

smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Reason for recall

Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.

Distribution

US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.

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-0277-2025