Recalls / —
—#202534
Product
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
- FDA product code
- HSB — Rod, Fixation, Intramedullary And Accessories
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K040462, K210980
- Affected lot / code info
- UDI/DI 03596010500922, Batch Number 21KSM0606
Why it was recalled
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 (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Smith & Nephew, Inc.
- Address
- 1450 E Brooks Rd, Memphis, Tennessee 38116-1804
Distribution
- Distribution pattern
- US, AE, CA, DE, ES, GB, MX, PA, PL
Timeline
- Recall initiated
- 2023-07-24
- Posted by FDA
- 2023-08-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #202534. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.