← Back to recalls

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

Class II
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.
Distribution pattern
International distribution to the countries of BE, DE, IT.
State
TN
Status
Ongoing
Recall number
Z-2456-2026
Recall initiated
March 16, 2026
View on openFDA