Recall Z-0282-2025
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 LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic
Codes / lots: UDI/DI 00885556234204, Batch number 23LM02905
Reason for recall
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT 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. Return affected product to: Smith+Nephew | Attn: Quality Hold and Field Action Returns Department | 1450 E Brooks Road, Building G | Memphis, TN 38116 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-0282-2025
- Initiated
- October 2, 2024
- Posted by FDA
- October 31, 2024
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Quantity
- 8 units
- Distribution
- US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada
- Recalling firm
- Smith & Nephew Inc, Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0281-2025 Class II | smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT…Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead… | 10/02/2024Open, Classified |