FDA-Device2024-11-06Class II
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Smith & Nephew Inc
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.
Sold states
US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.
Affected count
3 units
Manufactured in
6409 E Holmes Rd, N/A, Memphis, TN, United States
Products
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0277-2025Don't want to check this manually?
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