FDA Medical devices recall ·
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16 recall
- Recall number
- Z-2456-2026
- Date
- (initiated March 16, 2026)
- Company / brand
- Smith & Nephew, Inc.
1450 E Brooks Rd, Memphis, TN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 03596010514394. Lot/Batch: 25BM03616
Distribution
International distribution to the countries of BE, DE, IT.
States: Delaware
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2456-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.