Recall Z-0278-2025 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew Inc
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
| Date | Oct 30, 2024 (initiated Oct 2, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Packaging change control |
| Action | 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. |
| Quantity | 2 units |
| Distribution | US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043440 | SMITH & NEPHEW, INC. REVISION KNEE SYSTEM Smith & Nephew, Inc., Feb 18, 2005 |