Recall Z-2418-2015— Synthes (USA) Products LLC

Name: FDA recall Z-2418-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-29

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2015-07-29, terminated 2016-05-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.. Reason: Potential for micropores to form, allowing fluid to enter the hollow handle..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2015-07-29
Terminated: 2016-05-19
Firm location: West Chester, PA, United States

Product description

Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.

Reason for recall

Potential for micropores to form, allowing fluid to enter the hollow handle.

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