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FDAFDA · Food and drugs·Recall number Z-1758-2018

Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623

Published May 16, 2018 · Recall initiated: April 2, 2018

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Synthes (USA) Products LLC
Distributor
US Nationwide and Canada
Lot
Lot numbers: T104992, T114599, T140390, T140674, T140675, T140676, T140677, T141539, T143644, T144855, T145296, T145589, T145819, T146660, T147930, T148624, T149725, T149726, T151370, T152806, T152807, T153692, T155648, T156708, T160394, T939640, T987813
Risk classification
Class II
Area (FDA)
device
Country
United States

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