FDA-Device2016-02-10Class II
Synthes Small Electric Drive (SED). For use in general traumatology.
The Anspach Effort, Inc.
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.
Sold states
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.
Affected count
599 each
Manufactured in
4500 Riverside Dr, N/A, Palm Beach Gardens, FL, United States
Products
Synthes Small Electric Drive (SED). For use in general traumatology.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0747-2016Don't want to check this manually?
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