Recall Z-1600-2015— Synthes, Inc.

Name: FDA recall Z-1600-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-09

Class II · Terminated

Class II FDA medical device recall by Synthes, Inc., initiated 2015-04-09, terminated 2016-08-18. It names one FDA 510(k) clearance: K131548. Product: TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.. Reason: TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay..

Recalling firm: Synthes, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-04-09
Terminated: 2016-08-18
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 Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

Reason for recall

TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay.

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