Z-0341-2014Class II

Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal...

Name: Z-0341-2014 Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal...
Creator: Synthes USA HQ, Inc.
Published: 2013-09-24
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-09-24 / Terminated / root cause: design

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion on 2013-09-24. FDA classified it as Class II and gives the reason as "The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0341-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-24
Posted: 2013-11-18
Terminated: 2015-06-01
Recalling firm: Synthes GmbH
Product: Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Product code: GAD Retractor
Reason for recall: The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened.
Root cause tag: design
FDA root cause: Device Design
Action: Synthes sent an Urgent Notice: Medical Device Recall letter dated July 31, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and immediately remove the affected lots from stock, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the letter by checking the appropriate box indicating affected product has been located and return the Verification Form with the product to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers do not have the identified product, they were instructed to complete the Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.e attached Verification Section and return to Synthes.
Quantity in commerce: 374
Distribution: Worldwide Distribution - USA (Nationwide) and Canada.
Product codes and lots: Part # Lot # 325.01 1776332 325.01 1834589 325.01 1855361 325.01 1893067 325.01 1903596 325.01 1952258 325.01 1986932 325.01 3067805 325.01 3150691 325.01 3179456 325.01 3186865 325.01 3220973 325.01 3241083 325.01 3268079 325.01 3360992 325.01 3719234 325.01 3818913 325.01 4948929 325.01 4994679 325.01 4994680 325.01 5031083 325.01 5031085 325.01 5391773 325.01 5420979 325.01 5420980 325.01 5476369 325.01 5476370 325.01 5510070 325.01 5544585 325.01 5546329 325.01 5563699 325.01 5569041 325.01 5624246 325.01 5657366 325.01 5677289 325.01 5759764 325.01 5759765 325.01 5779363 325.01 7698954 325.01 7826103

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0341-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0341-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-18

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)