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Recall Observatory FDA recall evidence

Device product

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

Z-1759-2018

April 02, 2018

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 79850
Status
Terminated
Classification
Class II
Quantity
196
Official record key
device-enforcement:Z-1759-2018

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: 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

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.