Synthes Recalls Helical Blade Inserter for TFNA Due to Sizing Defect
Synthes (USA) Products LLC is recalling 32 units of the Helical Blade Inserter for TFNA because an oversized pin prevents the tool from passing through the guide sleeve.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect is a functional sizing issue that prevents the tool from passing through the guide sleeve, with no reported injuries or illnesses.
Plain-English summary
Synthes (USA) Products LLC is recalling 32 units of the Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA). The product is a manual orthopedic surgical instrument intended to secure the head element to the head element inserter to prevent disengagement during head element insertion.
The recall is due to a manufacturing defect where the height of one of the three guiding pins is oversized. As a result, the Helical Blade Inserter is unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017). The affected units are identified by Part Number 03.037.024 and Lot Number T102759.
The affected products were distributed nationwide. Healthcare facilities and users should stop using the affected instruments and contact Synthes (USA) Products LLC for instructions on return or replacement.
The recalled product
- Product
- Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 32
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)
- Part Number Lot Numbers 03.037.024 T102759
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Synthes (USA) Products LLC
See all →- HighVOLT locking screw taps swapped between lots carry incorrect thread
FDA (Devices) · 2026-04-08
- HighVOLT bone taps swapped between lots carry the incorrect thread
FDA (Devices) · 2026-04-08
- ModerateLocking bone screws recalled after packaging labeled with the wrong length
FDA (Devices) · 2025-10-29
- ModerateForty six millimetre locking screws recalled over wrong length on packaging
FDA (Devices) · 2025-10-29
- HighSurgical screwdrivers recalled for failure to engage with implant screws
FDA (Devices) · 2024-06-05
Same hazard · functional defect
See all →- ModerateMedline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
FDA (Devices) · 2026-10-21
- ModerateMerit Medical Systems Recalls Scout MD Delivery Systems Due to Deployment Issues
FDA (Devices) · 2026-10-21
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateSynthes Titanium Trochanteric Fixation Nail Recall for Non-Conforming Blades
FDA (Devices) · 2013-11-27
- ModerateDePuy Synthes Recalls TFNA Blade/Screw Guide Sleeves Due to Sizing Defect
FDA (Devices) · 2016-07-27
- HighSynthes Recalls Five TFN-Advanced Proximal Femoral Nailing Systems
FDA (Devices) · 2015-12-16
- ModerateSynthes Recalls TFNA Proximal Femoral Nails Due to Locking Mechanism Defect
FDA (Devices) · 2015-05-20
- SevereSynthes Recalls Titanium Elastic Nail Inserters Due to Mechanical Failure Risk
FDA (Devices) · 2015-10-21
- SevereSynthes Recalls Titanium Trochanteric Fixation Nail Systems Due to Missing Bend
FDA (Devices) · 2013-12-11