Recall Z-0747-2016— The Anspach Effort, Inc.

Name: FDA recall Z-0747-2016
Creator: U.S. Food and Drug Administration
Published: 2014-08-14

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2014-08-14, terminated 2016-02-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Synthes Small Electric Drive (SED). For use in general traumatology.. Reason: The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start..

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-08-14
Terminated: 2016-02-05
Firm location: Palm Beach Gardens, FL, United States

Product description

Synthes Small Electric Drive (SED). For use in general traumatology.

Reason for recall

The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.

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