United StatesTRIGEN Proximal Straight Humeral Nail 8/7 x 16 (REF 71760816, UDI‑DI 03596010514394, Lot 25BM03616), distributed in Belgium, Germany and Italy, is being recalled. A manufacturing error can leave the humeral nail missing distal holes, which if implanted may lead to revision surgery; if the missing holes are identified before implantation an equivalent backup or a bent nail of the same size can be used, though the bent nail requires additional soft tissue/bone preparation and could delay surgery by more than 30 minutes.
What's being recalled
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Recalling firm: Smith & Nephew, Inc., Memphis, TN, United States.
How to identify it
UDI-DI: 03596010514394. Lot/Batch: 25BM03616
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
International distribution to the countries of BE, DE, IT.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)