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Smith & Nephew Inc recalls smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELL
Recalled November 6, 2024 · FDA recall Z-0278-2025 · Smith & Nephew
Hazard
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. · FDA Class II
Units
2 units
Sold at
US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.
Description
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.
Product
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Manufacturer(s)
Smith & Nephew Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →