FDAClass IIMay 16, 2018

Retractor f/Sciatic Nerve recall

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

Why was Retractor f/Sciatic Nerve 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
Recalling firm
Synthes (USA) Products LLC
Quantity
235
Distribution
US Nationwide and Canada
Recall date
May 16, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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