Synthes Recalls Five TFN-Advanced Proximal Femoral Nailing Systems
Synthes (USA) Products LLC is recalling five TFN-Advanced Proximal Femoral Nailing Systems because a design defect may prevent proper locking mechanism advancement or screw tightening.
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: The recall involves a high-risk medical device where a mechanical failure could lead to improper fracture fixation, representing a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Synthes (USA) Products LLC is recalling five units of the TFN-Advanced Proximal Femoral Nailing System, specifically the Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile. The affected units are identified by Part Number 04.037.162S and Lot Number 7950511. These orthopedic intramedullary fixation rods are intended for the treatment of fractures.
The recall is due to a potential design defect where the locking mechanism may be positioned too close to the top of the nail. This issue may prevent the cannulated connecting screw from fully tightening the insertion handle to the nail, resulting in a loose or toggling nail. Alternatively, it may cause the bottom of the cannulated connecting screw to tighten against the top of the locking mechanism, preventing the advancement of the locking mechanism.
The affected products were distributed in the United States to the states of California, Florida, Michigan, and Wisconsin. The source text does not report any specific illnesses or injuries associated with this defect. Healthcare providers and facilities should check their inventory for the specific part and lot numbers listed and contact the manufacturer for further instructions.
The recalled product
- Product
- Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic.
- Manufacturer
- Synthes (USA) Products LLC
- 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)
- Part Number Lot Number 04.037.162S 7950511
Distribution
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