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Recall Observatory FDA recall evidence

Device product

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

Z-1758-2018

April 02, 2018

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 79850
Status
Terminated
Classification
Class II
Quantity
235
Official record key
device-enforcement:Z-1758-2018

Official wording

Reason: 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.

Code information: 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

Distribution pattern: US Nationwide and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.