TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16 recall (Smith & Nephew, Inc.)
Medical deviceClass IIOngoing
Summary: Smith & Nephew, Inc. is recalling TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816. Reason: 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.
What is being recalled
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
International distribution to the countries of BE, DE, IT.
How to tell if yours is affected
UDI-DI: 03596010514394. Lot/Batch: 25BM03616
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2456-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 16, 2026 |
| Reported | June 24, 2026 |
| Company | Smith & Nephew, Inc. |
| Company location | Memphis, TN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 5 |
More recalls from Smith & Nephew, Inc. · all medical device recalls · recalls from March 2026