Recall Z-0375-2016— Synthes (USA) Products LLC

Name: FDA recall Z-0375-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-02

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2015-11-02, terminated 2016-05-13. It names one FDA 510(k) clearance: K011857. Product: Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic.. Reason: TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the handle. Or 2. Cause the bottom of the cannulated connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2015-11-02
Terminated: 2016-05-13
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K011857 — SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEMSynthes (Usa)·cleared 2001-09-12

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

Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic.

Reason for recall

TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the handle. Or 2. Cause the bottom of the cannulated connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism.

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