Medical device recalls Moderate risk

The Anspach Effort, Inc. recalls Synthes Small Electric Drive (SED). For use in general traumatology.

Recall date
August 14, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0747-2016
FDA classification
Class II
Brand / firm
The Anspach Effort, Inc.
Sold / 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,…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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