Recall Z-1017-2016— The Anspach Effort, Inc.

Name: FDA recall Z-1017-2016
Creator: U.S. Food and Drug Administration
Published: 2014-11-14

Class II · Ongoing

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2014-11-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Synthes Small Electric Drive (SED). Reason: May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start..

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2014-11-14
Firm location: Palm Beach Gardens, FL, United States

Product description

Synthes Small Electric Drive (SED)

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.