FDA recall Z-1246-2023

Product

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

Distribution

Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan.

Key facts

Status

Ongoing

Initiation date

2023-02-01

Report date

2023-03-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1246-2023