Recall Z-2443-2023 ยท HSB Rod, Fixation, Intramedullary And Accessories
Smith & Nephew, Inc.
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
| Date | Aug 22, 2023 (initiated Jul 24, 2023) |
| Status | Open, Classified |
| Reason | A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label. |
| Root cause | Process control |
| Action | Smith & Nephew issued an Urgent Medical Device Recall Notice on 07/24/2023. The notice explained the problem with the product, the potential risk, and requested the consignees locate and quarantine the affected product for return. Sales reps, district offices, or distributors were directed to notify their customers and ensure that the required actions were complete. The firm is seeking return of the affected product. |
| Quantity | 30 units |
| Distribution | US, AE, CA, DE, ES, GB, MX, PA, PL |
| FDA record | Open on fda.gov |