Z-1758-2018Class II

Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623

Name: Z-1758-2018 Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
Creator: Synthes (USA) Products LLC
Published: 2018-04-02
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2018-04-02 / Terminated

FDA source

Synthes (USA) Products LLC began a recall of Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623 on 2018-04-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1758-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-02
Posted: 2018-05-09
Terminated: 2019-10-16
Recalling firm: Synthes (USA) Products LLC
Product: Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
Product code: GAD Retractor
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.
FDA root cause: Under Investigation by firm
Action: On April 2, 2018 Synthes (USA) LLC mailed an Urgent Product Recall notification letter to affected customers. Customers were instructed to: Review current inventory to identify and quarantine all affected products; Complete the Verification section of the Return Receipt form; Return affected product; Forward the notification to anyone in your facility that needs to be informed; If affected products have been forwarded to another facility, contact that facility to arrange return; Keep a copy of the notification. Customers with questions may call (610)719-5450 or contact your Depuy Synthese Sales Consultant.
Quantity in commerce: 235
Distribution: US Nationwide and Canada
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1758-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1758-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-09
Z-1759-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-09

Product code GAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)