Smith & Nephew Inc recalls smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATEL…

Recall date

October 2, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0278-2025

FDA classification

Class II

Brand / firm

Smith & Nephew Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER