PlainRecalls
FDA Devices Moderate Class II Ongoing

TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S

Reported: March 13, 2024 Initiated: January 24, 2024 #Z-1239-2024

Product Description

TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S

Reason for Recall

Products not sterilized, sterility cannot be confirmed

Details

Units Affected
11 units
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
Location
West Chester, PA

Frequently Asked Questions

What product was recalled?
TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S. Recalled by Synthes (USA) Products LLC. Units affected: 11 units.
Why was this product recalled?
Products not sterilized, sterility cannot be confirmed
Which agency issued this recall?
This recall was issued by the FDA Devices on March 13, 2024. Severity: Moderate. Recall number: Z-1239-2024.