FDA Device recall Z-1758-2018
Retractor f/Sciatic Nerve
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Retractor f/Sciatic Nerve by Synthes Usa Products, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1758-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-02 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
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.
Identifiers
| code_info | Lot numbers: T104992, T114599, T140390, T140674, T140675, T140676, T140677, T141539, T143644, T144855, T145296, T145589…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1758-2018%22
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