TFNA Femoral Nail surgical implant recalled for sterility failure
Synthes (USA) Products LLC is recalling 11 TFNA Femoral Nails (Lot 3744P37) because the products are not sterilized or sterility cannot be confirmed, posing infection risk.
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 a risk-of-harm product (surgical implant for bone fixation) where sterility failure poses direct infection risk. No illnesses or injuries have been reported. The FDA Class II classification combined with the critical nature of sterile surgical implants justifies a High severity rating.
Plain-English summary
Synthes (USA) Products LLC is recalling 11 TFNA Femoral Nails (9mm, right, 130°, L 235mm, Part Number 04.037.944S) due to sterility concerns. The recalled products, identified by Lot Number 3744P37 (UDI: 10886982098047), are not sterilized or sterility cannot be confirmed.
The TFNA Femoral Nail is a surgical implant intended for temporary fixation and stabilization of proximal femur fractures. Compromised sterility on implanted surgical devices poses a risk of serious infection.
The affected units were distributed worldwide, including throughout the United States and to Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, and South Africa. Healthcare providers who received these products should identify any units matching Lot Number 3744P37 and contact Synthes (USA) Products LLC for replacement and guidance.
The recalled product
- Product
- TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
- 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: 10886982098047 Lot Number: 3744P37
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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