Smith & Nephew, Inc.: Rod, Fixation, Intramedullary And Accessories
- Recalling firm
- Smith & Nephew, Inc.
- Product
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-16
- Status
- Open, Classified
- Areas affected
- DE
- Distribution
- International distribution to the countries of BE, DE, IT.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/4858ed59-8b1f-48b0-8de1-d8e96c6517b3