Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.
FDA Recall Z-0003-2012 · Posted 2011-10-03
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Recalling FirmCochlear Americas Inc.
Recall StatusTerminated
Product CodeMCM
Date Initiated2011-09-16
Date Terminated2012-07-10
Product Quantity33,645 units (global); 25,516 (implanted); 1,741 remaining in U.S. Market for implantation.
Reason for Recall
Cochlear implant may shut down and cease to function.
Firm Action
Cochlear Americas, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 16, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to examine their inventory and quarantine the affected product. A recall response form was attached to the letter for customers to complete and return. Contact Cochlear Clinic Customer Service at 877-883-3101 for questions concerning this notice.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution-USA (nationwide) and countries in Europe and Australia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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