CLASS II Device recall · Reported 10 Feb 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 nationwide in the US. The recall was initiated on 14 Aug 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots

Quantity recalled599 each

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-0747-2016
FDA event ID: 73000
Recalling firm: The Anspach Effort, Palm Beach Gardens, FL
Classification: Class II
Status: Terminated
Recall initiated: 14 Aug 2014
FDA classified: 3 Feb 2016
Reported: 10 Feb 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Aug 2014	Recall initiated by company
3 Feb 2016	Classified by FDA	+538 days
10 Feb 2016	Published in enforcement report	+7 days

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

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.

Product as listed by the FDA

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

Where it was distributed

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.

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

Questions about this recall

Why was it recalled?

The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.

Which lots are affected?

All Lots

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 26 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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