Data Foundry

Medical device recalls 2018

Retractor f/Sciatic Nerve Long — Class II medical device recall Z-1759-2018

Terminated recall by Synthes (USA) Products LLC, reported 2018-05-16, distributed nationwide. There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores ma

Recall numberZ-1759-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSynthes (USA) Products LLC, West Chester, PA, United States
Recall initiated2018-04-02
Classified2018-05-09
Reported by FDA2018-05-16
Terminated2019-10-16
DistributedNationwide (US)
Countries outside the USCA
Quantity196
UPC / GTIN / UDI-DI10886982070630
Lot numbersT104993, 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
Model numbers03.100.014

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1759-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.