RecallRadar

FDA Device recall Z-1246-2023

TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur frac…

On 2023-03-22 the FDA classified a Class II recall of TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur frac… by Synthes Usa Products, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1246-2023
ClassificationClass II
Statusongoing
Initiated2023-02-01
Published2023-03-22
Last updated2026-09-13 11:56 UTC
CompanySynthes Usa Products
DistributionUS

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

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

Identifiers

code_infoUDI-DI 10886982097033 Lot Number: 607P512

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1246-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.