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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