Recall Z-0125-2016— Synthes (USA) Products LLC

Name: FDA recall Z-0125-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-03

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2015-09-03, terminated 2016-10-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Inserter for Titanium Elastic Nails (TEN), orthopedic device. Reason: potential for mechanical failures such as breakage..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2015-09-03
Terminated: 2016-10-04
Firm location: West Chester, PA, United States

Product description

Inserter for Titanium Elastic Nails (TEN), orthopedic device

Reason for recall

potential for mechanical failures such as breakage.

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