Recall Z-2621-2023 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew Inc
smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
| Date | Sep 20, 2023 (initiated Aug 31, 2023) |
| Status | Open, Classified |
| Reason | The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label. |
| Root cause | Labeling Change Control |
| Action | Smith & Nephew issued an Urgent Medical Device3 Recall Notice to its consignees on 08/31/2023 via letter and email. The notice explained the problem and potential risk and requested the consignee quarantine the affected product. Distributors were directed to notify their customers. Firm is seeking return of the affected product. |
| Quantity | 8 units |
| Distribution | OH, CT, TX, NC, CA, NE, NV |
| FDA record | Open on fda.gov |