- Recalling firm
- Smith & Nephew, Inc.
- 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.
- Affected products (lot / model / serial)
- UDI-DI: 03596010514394. Lot/Batch: 25BM03616
- Units affected
- 5
- Distribution pattern
- International distribution to the countries of BE, DE, IT.
- Firm location
- Memphis, TN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2456-2026
- Recall initiated
- March 16, 2026
- FDA classification date
- June 16, 2026
- FDA report date
- June 24, 2026
- FDA event ID
- 98629
- Last updated on HTM Vibe
- July 24, 2026