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U.S. Department of Health and Human Services

Class 2 Device Recall CLARION 1.2, Advanced Bionics implantable cochlear stimulator

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 Class 2 Device Recall CLARION 1.2, Advanced Bionics implantable cochlear stimulatorsee related information
Date Initiated by FirmSeptember 27, 2004
Date PostedOctober 23, 2004
Recall Status1 Terminated 3 on July 13, 2005
Recall NumberZ-0044-05
Recall Event ID 30209
Product Classification Implant, Cochlear - Product Code MCM
ProductAdvanced Bionics implantable cochlear stimulator CLARION 1.2 Models AB-5100L AB-5100R AB-5100ML/R (For Export Only) AB-5100H AB-5100H-01A
Code Information Unimplanted CLARION 1.2
FEI Number 1000220815
Recalling Firm/
Manufacturer		 Advanced Bionics
12750 San Fernando Rd
Sylmar CA 91342-3728
For Additional Information ContactJeffrey 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
ActionExpanded 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.
DistributionU.S. and Canada and France
Total Product Life CycleTPLC 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.
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