Z-0429-2014Class II

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

Name: Z-0429-2014 Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the...
Creator: Synthes USA HQ, Inc.
Published: 2013-08-01
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-08-01 / Terminated

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 2013-08-01. FDA classified it as Class II and gives the reason as "The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0429-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-01
Posted: 2013-11-29
Terminated: 2015-04-16
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 small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.
FDA root cause: Use error
Action: Synthes sent an Field Safety Notification letter dated August 1, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to take the following actions: Exchange the old surgical technique guide with the new guide version F provided with this notification. Review the revised surgical technique guide. Forward this Field Safety Notification to anyone in your facility that needs to be informed. If the technique guide has been forwarded to another facility, contact that facility. Maintain awareness of this notice until all technique guides have been exchanged. Maintain a copy of this notice. Please complete and return this page by either of the following methods: Fax: 877-567-9320 or Scan/email: [email protected] Thank you for your attention to this issue.
Quantity in commerce: 374
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada and Mexico.
Product codes and lots: Part J5957AC (old), and Part J5957F (new)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0429-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0429-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-11-29

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)