Recall Z-2443-2023
Smith & Nephew, Inc. · initiated July 24, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
Codes / lots: UDI/DI 03596010500922, Batch Number 21KSM0598
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.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-2443-2023
- Initiated
- July 24, 2023
- Posted by FDA
- August 22, 2023
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 30 units
- Distribution
- US, AE, CA, DE, ES, GB, MX, PA, PL
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2444-2023 Class II | TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340…A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME… | 07/24/2023Open, Classified |