FDA recall, , Moderate risk
Smith & Nephew Trigen Proximal Straight Humeral Nail
The humeral nail is missing distal holes and may lead to revision surgery if implanted.
Summary by Recall Canary from the FDA notice
What happened
Smith & Nephew, Inc., of Memphis, Tennessee, recalled the Trigen Proximal Straight Humeral Nail 8/7 X 16, REF: 71760816, due to a manufacturing error missing distal holes.
If implanted, the nail may lead to revision surgery; 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.
The company began the recall on March 16, 2026, and the FDA added it to the Enforcement Report on June 16, 2026, with international distribution to the countries of BE, DE, IT.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI, lot code and reference number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Trigen Proximal Straight Humeral Nail 8/7 X 16
- UDI-DI
- 03596010514394
- Reference number
- 71760816
- Lot code
- 25BM03616
Recall details
- Company began the recall
- Sold in
International distribution to the countries of BE, Delaware, IT.
- Company
- Smith & Nephew, Inc.Memphis, Tennessee
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98629
- Recall number
- Z-2456-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
