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.
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 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
- Hazard
- sterilization-failure
- infection-risk
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.
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