Z-2418-2015Class II

Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic...

Name: Z-2418-2015 Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic...
Creator: Synthes (USA) Products LLC
Published: 2015-07-29
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2015-07-29 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific... on 2015-07-29. FDA classified it as Class II and gives the reason as "Potential for micropores to form, allowing fluid to enter the hollow handle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2418-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-29
Posted: 2015-08-19
Terminated: 2016-05-19
Recalling firm: Synthes (USA) Products LLC
Product: Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.
Product code: GAD Retractor
Reason for recall: Potential for micropores to form, allowing fluid to enter the hollow handle.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Urgent recall letters, dated July 29,2015, were sent to end users and sales consultants to inform them of the issue, potential risks, and to provide instructions for returning affected devices and the response form.
Quantity in commerce: 1113
Distribution: Nationwide and internationally, including Canada
Product codes and lots: Part Numbers 03.100.013 03.100.014 with lot numbers: 5001180 5001181 5043720 5043721 5043722 5043723 5056224 5056410 5056411 5101097 5106064 5109323 5162016 5207917 5252353 5252354 5303914 5303916 5626912 904732 / A7OA43 908057 / A7PA10 909551 / A7PA20 910819 / A7PA30 T100870 T104992 T108114 T114599 T938508 T939338 T939640 T942069 T945414 T946497 T949375 T954443 T958062 T963371 T968151 T968381 T972086 T974174 T974550 T977901 T980418 T980555 T983069 T984285 T987813 T993091 T996572 T999967 5001182 5001183 5042920 5042921 5042922 5042923 5056851 5087081 5087082 5109324 5109325 5109326 5109327 5162012 5207918 5252394 5256421 5256479 5256480 5305758 5305759 5305760 5877095 6040220 6040225 6040226 6056133 6056134 903786 / A7OA37 904731 / A7OA43 908058 / A7PA10 909552 / A7PA20 910911 / A7PA31 T100871 T104993 T108115 T114598 T932954 T935264 T939339 T945413 T946498 T947785 T954444 T958061 T963372 T968152 T974175 T977904 T980511 T983070 T984228 T987809 T989000 T993092 T996565 T999969

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2418-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2418-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19

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)