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Recall Observatory FDA recall evidence

Device product

Synthes Small Electric Drive (SED)

Z-1017-2016

November 14, 2014

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 69974
Status
Ongoing
Classification
Class II
Quantity
302 (23 in the USA and 279 OUS)
Official record key
device-enforcement:Z-1017-2016

Official wording

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

Code information: All lots from production launch

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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