FDA-Device2016-03-02Class II

Synthes Small Electric Drive (SED)

The Anspach Effort, Inc.
Hazard

May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.

Sold states
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, Zaire, Taiwan, and Australia.
Affected count
302 (23 in the USA and 279 OUS)
Manufactured in
4500 Riverside Dr, N/A, Palm Beach Gardens, FL, United States
Products
Synthes Small Electric Drive (SED)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1017-2016

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