Recall Z-1246-2023— Synthes (USA) Products LLC

Name: FDA recall Z-1246-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-01

Class II · Ongoing

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2023-02-01. It names one FDA 510(k) clearance: K131548. 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.

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-02-01
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K131548 — SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEMSynthes (USA) Products, LLC·cleared 2014-02-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.