TRIGEN proximal humeral nails are missing their distal holes
TRIGEN Proximal Straight Humeral Nails 8/7 x 16 are being recalled because a manufacturing error left them missing distal holes. Five units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where an out-of-specification implant could require revision surgery if implanted, a risk of harm with no injuries reported.
Plain-English summary
The TRIGEN Proximal Straight Humeral Nail 8/7 x 16, REF 71760816, UDI-DI 03596010514394, lot 25BM03616, from Smith & Nephew, Inc., is being recalled. The action covers five units.
Due to a manufacturing error the humeral nail is missing distal holes. According to the manufacturer, if implanted this may lead to revision surgery; 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 and bone preparation and could lead to a surgical delay of greater than 30 minutes. The FDA classified the action as Class II.
Distribution was international, to Belgium, Germany and Italy. The nails are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the REF, UDI-DI and lot number above, quarantine it, and follow the instructions issued by Smith & Nephew.
The recalled product
- Product
- TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 03596010514394. Lot/Batch: 25BM03616
Distribution
Distributed in 1 state:
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