Trigen Proximal Straight Humeral Nail 8/7 X 16 recall
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Why was Trigen Proximal Straight Humeral Nail 8/7 X 16 recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 03596010514394. Lot/Batch: 25BM03616
- Product
- TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 5
- Distribution
- International distribution to the countries of BE, DE, IT.
- Recall date
- June 24, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)