PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: March 22, 2023 Initiated: February 1, 2023 #Z-1246-2023

Product Description

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

Reason for Recall

TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length

Details

Units Affected
6 units
Distribution
Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan.
Location
West Chester, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by Synthes (USA) Products LLC. Units affected: 6 units.
Why was this product recalled?
TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
Which agency issued this recall?
This recall was issued by the FDA Devices on March 22, 2023. Severity: Moderate. Recall number: Z-1246-2023.