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U.S. Department of Health and Human Services

Class 2 Device Recall Harmony HiResolution Bionic Ear system

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  Class 2 Device Recall Harmony HiResolution Bionic Ear system see related information
Date Initiated by Firm June 10, 2009
Date Posted September 11, 2009
Recall Status1 Terminated 3 on March 26, 2012
Recall Number Z-2039-2009
Recall Event ID 52700
PMA Number P960058 
Product Classification Implant, cochlear - Product Code MCM
Product Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case.

Cochlear implant intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
Code Information Serial Numbers: 225271, 301184, 225466, 225647, 225289, 225187, 300922, 225629, 225512, 301129, 300926, 225272, 225373, 300980, 225281, 225423, 225540 and 301027.
Recalling Firm/
Manufacturer		 Advanced Bionics LLC
12740 San Fernando Rd
Sylmar CA 91342-3728
For Additional Information Contact
661-362-7500
Manufacturer Reason
for Recall		 The recall was initiated after Advanced Bionics became aware of fourteen (14) devices manufactured between May 27, 2005 and June 30, 2005 that are confirmed to have or potentially have an issue related to the internal magnet. These devices are were made with an internal magnet where the metal case surrounding the magnet was not properly welded. Patients with these devices may experience a decreas
FDA Determined
Cause 2		 Process control
Action Advanced Bionics, LLC issued an "Important Notification" dated June 10, 2009 via Fed Ex to Consignees in the US and Canada. Outside of the US, the notification letters will be distributed in such a manner that delivery confirmation can be obtained. There were three type of notification letters distributed: one for Patients, one for Surgeons and one for Clinicians. Letters described the affected device prompting users on what to do next. An acknowledgement form was enclosed and should be completed and sent via fax to 1-661-362-7621. For further information, contact Advanced Bionics at 1-877-829-0026.
Quantity in Commerce 18
Distribution Worldwide Distribution -- US, Canada, France and South Korea.
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 = ADVANCED BIONICS
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