| Class 2 Device Recall NUCLEUS COCHLEAR IMPLANT SYSTEM | |
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
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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
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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 |
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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.
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PMA Database | PMAs with Product Code = MCM
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