Z-1017-2016Class II

Synthes Small Electric Drive (SED)

Name: Z-1017-2016 Synthes Small Electric Drive (SED)
Creator: The Anspach Effort, Inc.
Published: 2014-11-14
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2014-11-14 / Open, Classified

FDA source

The Anspach Effort, Inc. began a recall of Synthes Small Electric Drive (SED) on 2014-11-14. FDA classified it as Class II and gives the reason as "May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1017-2016
Classification: Class II
Status: Open, Classified
Initiated: 2014-11-14
Posted: 2016-02-25
Recalling firm: The Anspach Effort, Inc.
Product: Synthes Small Electric Drive (SED)
Product code: HTC Pliers, Surgical
Reason for recall: May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.
FDA root cause: Other
Action: On November 13, 2014 DePuySynthes sent a letter to all their consignees informing them of the recall and asked them to return the product. A letter and a response letter were sent to all customers that received the device. For contact - The Complaint Handling Unit Manager at 561-494-3673 or the customer DePuy Synthes Sales Consultant.
Quantity in commerce: 302 (23 in the USA and 279 OUS)
Distribution: CO, FL, LA, ID, CA, KS, IL, TX, VA, MI, NC, WA, AR, NY, NC, AZ, and Hawaii Canada, Hong Kong, Chile, Israel, Poland, Turkey, Itly, Malaysia, Ireland, Korea, Germany, Spain, Norway, Sweeden, England, Fiji, Switzerland, Belgium, Austria, Netherlands, France, Japan, China, India, Thailand, Russia, Zaire, Taiwan, and Australia.
Product codes and lots: All lots from production launch

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1017-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1017-2016	Class II	Ongoing	Voluntary: Firm initiated	2016-03-02	2016-02-25

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)