Recall Z-0277-2025
Smith & Nephew Inc · initiated October 2, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Codes / lots: UDI/DI 03596010543820, Batch Number 23LM00479
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.
FDA-determined cause: Packaging change control
Action taken
Smith & Nephew issued an "Urgent Medical Device Recall Notice" to its consignees on 10/02/2024 via email. The notice explained the issue, potential risk of use of the affected product, and requested the return of the affected devices. Distributors, sales reps, and district offices were directed to notify their customers. If you have any questions or concerns regarding this recall please contact FieldActions@smith nephew.com.
Details
- Recall number
- Z-0277-2025
- Initiated
- October 2, 2024
- Posted by FDA
- October 30, 2024
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Quantity
- 3 units
- Distribution
- US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.
- Recalling firm
- Smith & Nephew Inc, Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0278-2025 Class II | smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF…Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a… | 10/02/2024Open, Classified |