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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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:
Related recalls
Same manufacturer · Smith & Nephew, Inc.
See all →- ModerateBone fixation screws recalled over a labeling error on one lot
FDA (Devices) · 2025-12-24
- ModerateSmith & Nephew Lag/Compression Screw Kit Undersized Socket Defect
FDA (Devices) · 2025-05-28
- HighBIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
FDA (Devices) · 2024-12-11
- HighSmith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring
FDA (Devices) · 2024-11-13
- HighSmith & Nephew Knee Prosthesis Recalled for Wrong Size Shipped
FDA (Devices) · 2024-11-06
Same hazard · manufacturing error
See all →- HighStraumann custom abutments made from wrong bar material after mix-up
FDA (Devices) · 2026-04-01
- HighStraumann angled custom abutments made from wrong bar material
FDA (Devices) · 2026-04-01
- HighMedtronic tissue stabilizer recalled after tubing was assembled in reverse
FDA (Devices) · 2026-03-04
- HighDASH COVID and flu tests may give a false negative result
FDA (Devices) · 2025-08-13
- ModerateBostonSight scleral lenses made with sagittal height or haptic errors
FDA (Devices) · 2025-08-06
Similar recalls
- HighSmith & Nephew Recalls Trigen Intertan Nails Due to Manufacturing Error
FDA (Devices) · 2014-08-27
- SevereSmith & Nephew Recalls Trigen Intertan 1.5 Nails Due to Manufacturing Error
FDA (Devices) · 2014-05-28
- ModerateSmith & Nephew Recalls TRIGEN Intramedullary Nail Sleeves Due to Sterilization Error
FDA (Devices) · 2020-07-29
- ModerateSmith & Nephew Recalls Trigen Intertan Bone Fixation Nails for Packaging Error
FDA (Devices) · 2021-01-13
- ModerateSmith & Nephew Recalls Intertan 10S Orthopedic Nails Due to Assembly Error
FDA (Devices) · 2017-11-22
- LowSynthes Titanium Humeral Nail Recalled for Incorrect Packaging Labeling
FDA (Devices) · 2013-12-04