Class II

Medical Device Recall: TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816

Smith & Nephew, Inc. · March 16, 2026

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.

Distribution

International distribution to the countries of BE, DE, IT.

States Affected

DE

Quantity Affected

5

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2456-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.