FDAFDA · Food and drugs·Recall number Z-0277-2025
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Published November 6, 2024 · Recall initiated: October 2, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Smith & Nephew Inc
- Distributor
- US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.
- Lot
- UDI/DI 03596010543820, Batch Number 23LM00479
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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