Recall Z-1352-2015— Synthes, Inc.

Name: FDA recall Z-1352-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-24

Class II · Terminated

Class II FDA medical device recall by Synthes, Inc., initiated 2015-02-24, terminated 2015-09-21. It names one FDA 510(k) clearance: K131548. Product: Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.. Reason: The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments..

Recalling firm: Synthes, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-02-24
Terminated: 2015-09-21
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

Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

Reason for recall

The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.

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