Synthes TFN-Advanced Femoral Nail Recalled for Dimensional Labeling Mismatch
Synthes (USA) Products LLC is recalling TFN-Advanced Femoral Nails because labeled measurements do not match actual dimensions. Nails labeled 200mm may be 170mm and vice versa.
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 involving dimensional labeling errors on surgical implants. No hospitalizations or injuries reported in source material, but incorrect implant dimensions pose potential surgical risk if undetected.
Plain-English summary
Synthes (USA) Products LLC is recalling TFN-Advanced Femoral Nails (Part Number 04.037.213S, Lot 607P512) used for temporary fixation and stabilization of proximal femur fractures. The affected nails are labeled and etched with incorrect dimensions: nails labeled 200mm in length may actually measure 170mm, and nails labeled 170mm may actually measure 200mm.
This dimensional discrepancy could affect surgical outcomes if the actual implant size differs significantly from what the surgeon expects based on the labeling. Healthcare providers depend on accurate labeling to select appropriately sized implants for each patient.
The recalled nails were distributed to facilities in Mississippi, Oregon, and Texas in the United States, as well as to Canada and Japan. A total of 6 units were affected (Lot 607P512).
Healthcare providers and facilities that received these nails should stop using them and contact Synthes immediately. Patients who may have received these implants should consult with their healthcare provider about their implant dimensions and whether any follow-up is needed.
The recalled product
- Product
- TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 6
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 10886982097033 Lot Number: 607P512
Distribution
Part of a larger recall action
This product is one of 3 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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