Recall Z-0281-2025 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew Inc
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
| Date | Oct 31, 2024 (initiated Oct 2, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| 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. 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. |
| Quantity | 5 units |
| Distribution | US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962557 | GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT Smith & Nephew Richards, Inc., Dec 5, 1996 |