TFN-Advanced Femoral Nails May Have Incorrect Length Markings
Synthes TFN-Advanced Femoral Nails labeled as 200mm may measure 170mm, and vice versa. Healthcare providers should verify actual dimensions before surgical use.
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: This is a risk-of-harm medical device where incorrect dimensions could compromise surgical outcomes, classified as FDA Class II. No injuries or illnesses have been reported, which limits the score to 3 per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Synthes (USA) Products LLC is recalling TFN-Advanced Femoral Nails (part number 04.037.212S) intended for fixation and stabilization of proximal femur fractures. The recalled nails have labeling and etching discrepancies: nails labeled and etched as 200mm may actually measure 170mm in length, and nails labeled and etched as 170mm may actually measure 200mm in length.
The affected product was distributed nationwide in Mississippi, Oregon, and Texas, as well as in Canada and Japan. The lot number is 611P035 with UDI-DI: 10886982097026.
The incorrect dimensions could result in improper fixation and stabilization of proximal femur fractures during surgery. No injuries or illnesses have been reported to date.
Healthcare facilities should stop using nails from the recalled lot and verify the actual dimensions of any TFN-Advanced Femoral Nails before surgical use. Patients who received these nails should contact their healthcare provider for guidance.
The recalled product
- Product
- TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- dimension-mismatch
- mislabeling
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: 10886982097026 Lot Number: 611P035
Distribution
Distributed nationwide across the United States.
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