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Recall

Class II — The Anspach Effort, Inc.

Recalling firmTHE ANSPACH EFFORT, INC.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonMay operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.
ProductSynthes Small Electric Drive (SED)
Quantity302 (23 in the USA and 279 OUS)
DistributionCO, 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.
Initiated2014-11-14
Classified2016-02-25
Recall numberZ-1017-2016
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — The Anspach Effort, Inc. (Z-1017-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69974/

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