Z-0747-2016Class II

Synthes Small Electric Drive (SED). For use in general traumatology

Name: Z-0747-2016 Synthes Small Electric Drive (SED). For use in general traumatology
Creator: The Anspach Effort, Inc.
Published: 2014-08-14
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2014-08-14 / Terminated / root cause: manufacturing process

FDA source

The Anspach Effort, Inc. began a recall of Synthes Small Electric Drive (SED). For use in general traumatology on 2014-08-14. FDA classified it as Class II and gives the reason as "The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start". 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-0747-2016
Classification: Class II
Status: Terminated
Initiated: 2014-08-14
Posted: 2016-02-03
Terminated: 2016-02-05
Recalling firm: The Anspach Effort, Inc.
Product: Synthes Small Electric Drive (SED). For use in general traumatology.
Product code: HTC Pliers, Surgical
Reason for recall: The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 11/13/2014 DePuy Synthes send a letter to all their customers informing them of the recall of all the lots of the Small Electric Drive (SED) with instructions to returned and possible exchange. Contact is Complaint Handling Unit Manager at 561-494-3673
Quantity in commerce: 599 each
Distribution: Worldwide Distribution-US (nationwide) including the states of AR, AZ, CA, CO, FL, ID, IL, KS, LA, MI, NC, NY, TX, WA, VA and HI, and the countries of Germany, Hong Kong, Chile, Israel, Poland, Italy, Turkey, Italy, Singapore, Ireland, Korea, Spain, Norway, Denmark, Great Britain, Finland, Belgium, Netherlands, France, Japan, Sweden, Switzerland, Austria, China, India, Thailand, Russia, New Zealand, Zaire, Australia, Taiwan, and Malaysia.
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0747-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0747-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-02-03

Product code HTC

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)