FDA Medical Device Recalls (openFDA)
Synthes (USA) Products LLC: Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
- Recall number
- Z-1758-2018
- Recalling firm
- Synthes (USA) Products LLC
- Product
- Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
- Status
- Terminated
- Initiated
- 2018-04-02
- Posted
- not on file
- Terminated
- 2019-10-16
- 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.
- 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
- 235
- Distribution
- US Nationwide and Canada
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAD
- Firm FEI
- 3008812560
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28