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.
What this means for you
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.
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