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U.S. Department of Health and Human Services

Class 2 Device Recall HiRes 90, Model CI140001, Advanced Bionics implantable cochlear stimulator

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  Class 2 Device Recall HiRes 90, Model CI140001, Advanced Bionics implantable cochlear stimulator see related information
Date Initiated by Firm September 27, 2004
Date Posted October 23, 2004
Recall Status1 Terminated 3 on July 13, 2005
Recall Number Z-0046-05
Recall Event ID 30209
PMA Number P960058S030 
Product Classification Implant, Cochlear - Product Code MCM
Product Advanced Bionics implantable cochlear stimulator HiRes 90,

Models
CI-1400-01
CI-1400-02
Code Information HiRes 90K Implantable Cochlear Stimulator, Model Number CI-1400-01, manufactured prior to December 1, 2003.
Recalling Firm/
Manufacturer		 Advanced Bionics
12750 San Fernando Rd
Sylmar CA 91342-3728
For Additional Information Contact Jeffrey H. Greiner
877-454 Ext. 5038
Manufacturer Reason
for Recall		 All unimplanted CLARION and HiResolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning.
FDA Determined
Cause 2		 Other
Action Expanded recall was initiated with notification to clinicians on 9/27/2004. Expanded effort includes: notice to patients implanted, notice to clinicians, worldwide return of all unimplanted coclear implants.
Quantity in Commerce 46 units
Distribution U.S. and Canada and France
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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