Recall Z-2456-2026
- Recall number
- Z-2456-2026
- Event number
- 98629
- Firm
- Smith & Nephew, Inc.
- Firm FEI
- 1020279
- Product code
- HSB
- Status
- Open, Classified
- Initiated
- 2026-03-16
- Posted
- 2026-06-16
- Root cause
- Process control
- 510(k) numbers
- K210980, K203819, K200430, K972811, K960524, K100112, K920666, K113409, K220679, K111056, K241484, K230071, K884407, K955761, K131490, K013923, K172943, K033618, K090241, K012158, K130625, K150867, K952739, K013524, K971056, K022225, K091566, K111444, K021744, K040336
Product#
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Reason for Recall#
Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.