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The Anspach Effort, Inc. recalls Synthes Small Electric Drive (SED). For use in general traumatology.
Recalled February 10, 2016 · FDA recall Z-0747-2016 · The Anspach Effort
Hazard
The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. · FDA Class II
Units
599 each
Sold at
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.
Description
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
Synthes Small Electric Drive (SED). For use in general traumatology.
Manufacturer(s)
The Anspach Effort, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →