Z-1759-2018 Class II Terminated

Recalled by Synthes (USA) Products LLC — West Chester, PA

Recall Details

Product Type
Devices
Report Date
May 16, 2018
Initiation Date
April 2, 2018
Termination Date
October 16, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
196

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.

Distribution Pattern

US Nationwide and Canada

Code Information

Lot numbers: T104993, T108115, T114598, T140566, T140665, T140670, T140671, T140673, T141540, T143687, T144854, T145585, T145590, T145932, T146657, T147929, T148552, T148553, T149727, T149728 T151369, T151488, T152808, T152809, T153884, T155649, T958061