Recall Z-1918-2014— The Anspach Effort, Inc.

Name: FDA recall Z-1918-2014
Creator: U.S. Food and Drug Administration
Published: 2012-11-28

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2012-11-28, terminated 2014-08-07. FDA's recall record names no specific 510(k) clearance for this event. Product: ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to be used with Anspach Systems. Reason: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements..

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-11-28
Terminated: 2014-08-07
Firm location: Palm Beach Gardens, FL, United States

Product description

ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to be used with Anspach Systems

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

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