CLASS II ONGOING Device recall · Reported 2 Mar 2016 · FDA Enforcement Report

Synthes Small Electric Drive (SED) recalled by The Anspach Effort

The Anspach Effort is recalling Synthes Small Electric Drive (SED), distributed in 16 states. The recall was initiated on 14 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots from production launch

Quantity recalled302 (23 in the USA and 279 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1017-2016
FDA event ID: 69974
Recalling firm: The Anspach Effort, Palm Beach Gardens, FL
Classification: Class II
Status: Ongoing
Recall initiated: 14 Nov 2014
FDA classified: 25 Feb 2016
Reported: 2 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Nov 2014	Recall initiated by company
25 Feb 2016	Classified by FDA	+468 days
2 Mar 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.

Product as listed by the FDA

Synthes Small Electric Drive (SED)

Where it was distributed

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.

Arkansas Arizona California Colorado Florida Hawaii Idaho Illinois Kansas Louisiana Michigan North Carolina New York Texas Virginia Washington

Questions about this recall

Is Synthes Small Electric Drive (SED) recalled?

Yes. The Anspach Effort recalled Synthes Small Electric Drive (SED) on 14 Nov 2014. The recall is Class II and its status is Ongoing. Recall number Z-1017-2016.

Why was it recalled?

May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.

Which lots are affected?

All lots from production launch

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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