Medical Device Recall: Z-0044-05

FDA Recalls dataset · Firm: Advanced Bionics · Status: Terminated

Recall Action Class: N/A Date Initiated: 2004-09-27 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0044-05.

Recall Res Number
Z-0044-05
Recalling Firm / Manufacturer
Advanced Bionics
FEI Number
1000220815
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2004-09-27
Date Posted
2004-10-23
Date Terminated
2005-07-13
Product Code
MCM
Event Number
30209
Product Quantity
N/A
Product Description Advanced Bionics implantable cochlear stimulator CLARION 1.2 Models AB-5100L AB-5100R AB-5100ML/R (For Export Only) AB-5100H AB-5100H-01A
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.
Action Details 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.
Distribution Pattern U.S. and Canada and France
Code Information / Serial Numbers Unimplanted CLARION 1.2

Related Establishments / Registrations

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