TFNA Femoral Nail Recalled Due to Sterility Confirmation Issue
Synthes is recalling 11 TFNA Femoral Nails due to sterility failures. The affected units worldwide cannot be confirmed as sterilized and pose infection risks to patients.
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: This is an FDA Class II recall of a surgical implant with no reported illnesses or injuries to date. The sterility failure represents a risk-of-harm product where infection has not yet been reported, meeting the criteria for High severity per the rubric.
Plain-English summary
Synthes (USA) Products LLC is recalling TFNA Femoral Nails (11mm, right, 130°, L 235mm, Part Number 04.037.144S, Lot 4489P98) worldwide due to a sterility issue. The manufacturer has determined that the 11 units distributed cannot be confirmed as sterilized, which is a critical requirement for surgical implants intended for direct patient use.
The affected units have been distributed worldwide, including to the United States and the following countries: Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, and Taiwan. These femoral nails are intended for temporary fixation and stabilization of proximal femur fractures during orthopedic surgery.
Unsterilized or potentially non-sterile surgical implants pose a significant infection risk to patients. Healthcare providers and patients who have received these implants should contact their healthcare provider immediately to discuss appropriate follow-up care and potential replacement of the affected device.
The recalled product
- Product
- TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 11
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: 10886982096562 Lot Number: 4489P98
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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