Recall Z-2086-2015— Synthes (USA) Products LLC

Name: FDA recall Z-2086-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-24

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2015-06-24, terminated 2016-08-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.. Reason: It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2015-06-24
Terminated: 2016-08-18
Firm location: West Chester, PA, United States

Product description

16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.

Reason for recall

It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.

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