PlainRecalls
FDA Devices Moderate Class II Terminated

Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630

Reported: May 16, 2018 Initiated: April 2, 2018 #Z-1759-2018

Product Description

Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630

Reason for Recall

There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.

Details

Units Affected
196
Distribution
US Nationwide and Canada
Location
West Chester, PA

Frequently Asked Questions

What product was recalled?
Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630. Recalled by Synthes (USA) Products LLC. Units affected: 196.
Why was this product recalled?
There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1759-2018.