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U.S. Department of Health and Human Services

Class 2 Device Recall Cochlear Nucleus CI512 Cochlear Implant

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  Class 2 Device Recall Cochlear Nucleus CI512 Cochlear Implant see related information
Date Initiated by Firm September 16, 2011
Date Posted October 03, 2011
Recall Status1 Terminated 3 on July 10, 2012
Recall Number Z-0003-2012
Recall Event ID 59979
PMA Number P970051 
Product Classification Implant, cochlear - Product Code MCM
Product 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.
Code Information Part Number Z209051 all codes.
Recalling Firm/
Manufacturer		 Cochlear Americas Inc.
13059 E Peakview Ave
Englewood CO 80111-6511
For Additional Information Contact Sean Bundy
303-524-7139
Manufacturer Reason
for Recall		 Cochlear implant may shut down and cease to function.
FDA Determined
Cause 2		 Component design/selection
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.
Quantity in Commerce 33,645 units (global); 25,516 (implanted); 1,741 remaining in U.S. Market for implantation.
Distribution Worldwide Distribution-USA (nationwide) and countries in Europe and Australia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MCM and Original Applicant = Cochlear Americas
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