Medical device recalls Moderate risk

The Anspach Effort, Inc. recalls Synthes Small Electric Drive (SED)

Recall date
November 14, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1017-2016
FDA classification
Class II
Brand / firm
The Anspach Effort, Inc.
Sold / 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, Zai…

Why it was recalled

May operate solely in reverse mode, not operate in reverse mode when intended, not function or an 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)

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