smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELL
FDA device recall Z-0277-2025 · posted 2024-10-30 · Open, Classified
Recall details
- Recalling firm
- Smith & Nephew Inc
- 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.
- 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.
- Root cause
- Packaging change control
- Status
- Open, Classified
- Product code
- JWH
- Quantity affected
- 3 units
- Distribution
- US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.
- Date initiated
- 2024-10-02
- Date posted
- 2024-10-30
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMITH & NEPHEW, INC. REVISION KNEE SYSTEM (K043440) | Smith & Nephew, Inc. | 2005-02-18 |