FDA DevicesClass II
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Published: June 24, 2026Recall ID: Z-2456-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Additional Source Details
| Field | Value |
|---|---|
| City | Memphis |
| State | TN |
| Event id | 98629 |
| Address 1 | 1450 E Brooks Rd |
| Code info | UDI-DI: 03596010514394. Lot/Batch: 25BM03616 |
| Postal code | 38116-1804 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 5 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260316 |
| Initial firm notification | Letter |
| Center classification date | 20260616 |
Overview
- Recalling FirmSmith & Nephew, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionInternational distribution to the countries of BE, DE, IT.