Z-0277-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2024
- Initiation Date
- October 2, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
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.
Distribution Pattern
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