Retractor f/Sciatic Nerve — Class II medical device recall Z-1758-2018
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 number | Z-1758-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2018-04-02 |
| Classified | 2018-05-09 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2019-10-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 235 |
| UPC / GTIN / UDI-DI | 10886982070623 |
| 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 |
| Model numbers | 03.100.013 |
Product
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
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-1758-2018. 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.