smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; P...
FDA Recall #Z-0277-2025 — Class II — October 2, 2024
Product Description
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.
Recalling Firm
Smith & Nephew Inc — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3 units
Distribution
US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.
Code Information
UDI/DI 03596010543820, Batch Number 23LM00479
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated