TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
FDA device recall Z-2443-2023 · posted 2023-08-22 · Open, Classified
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HSB
- Quantity affected
- 30 units
- Distribution
- US, AE, CA, DE, ES, GB, MX, PA, PL
- Date initiated
- 2023-07-24
- Date posted
- 2023-08-22
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Smith & Nephew Intramedullary Nail Systems (K210980) | Smith & Nephew, Inc. | 2022-11-14 |
| TRIGEN TROCHANTERIC ANTEGRADE NAIL (K040462) | Smith & Nephew, Inc. | 2004-03-23 |