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U.S. Department of Health and Human Services

Class 2 Device Recall NUCLEUS COCHLEAR IMPLANT SYSTEM

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  Class 2 Device Recall NUCLEUS COCHLEAR IMPLANT SYSTEM see related information
Date Initiated by Firm September 30, 2009
Date Posted November 02, 2009
Recall Status1 Terminated 3 on December 22, 2009
Recall Number Z-0119-2010
Recall Event ID 53492
PMA Number P970051 
Product Classification Cochlear implant - Product Code MCM
Product Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.
Code Information Part No. Z-50100.
Recalling Firm/
Manufacturer		 Cochlear Americas Inc.
13059 E Peakview Ave
Englewood CO 80111-6511
For Additional Information Contact Deborah Arthur
303-200-5426
Manufacturer Reason
for Recall		 Cochlear implant device component was mis-labeled.
FDA Determined
Cause 2		 Labeling mix-ups
Action On September 28, 2009, each surgeon who received a non-magnetic plug after December 5, 2008 was sent a notification letter via courier. The letter described the mislabeling issue and actions for consignees. Customers were requested to return affected product (and the quantity discarded) to the firm and review patient records to verify the implantation of the non-magnetic plug and not the mislabled product (sterile magnetic). Direct questions about the recall by calling at 1-800-523-5798.
Quantity in Commerce 10 units
Distribution Worldwide Distribution -- United States (AL, AZ, CA, GA, IA, NC, MA, MI, MN, MO, NY, OH, OR, PA, TN, TX and WA), Brazil, and Argentina.
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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