Z-1758-2018 Class II Terminated
FDA device recall Z-1758-2018 was initiated by Synthes (USA) Products LLC on Apr 2, 2018 and is designated Class II. 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. The recall status is terminated (terminated Oct 16, 2019). Affected quantity: 235.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- Apr 2, 2018
- Termination Date
- Oct 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 235
Product Description
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.
Distribution Pattern
US Nationwide and Canada
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1758-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026