PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 26, 2015 Initiated: July 29, 2015 #Z-2418-2015

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.

Details

Units Affected
1113
Distribution
Nationwide and internationally, including Canada
Location
West Chester, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Synthes (USA) Products LLC. Units affected: 1113.
Why was this product recalled?
Potential for micropores to form, allowing fluid to enter the hollow handle.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 26, 2015. Severity: Moderate. Recall number: Z-2418-2015.