Advanced Bionics implantable cochlear stimulator CLARION 1.2 Models AB-5100L AB-5100R AB-5100ML/R (For Export Only) AB-5
FDA device recall Z-0044-05 · posted 2004-10-23 · Terminated
Recall details
- Recalling firm
- Advanced Bionics
- 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 taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MCM
- Distribution
- U.S. and Canada and France
- Date initiated
- 2004-09-27
- Date posted
- 2004-10-23
- Date terminated
- 2005-07-13
- Location
- Sylmar, CA
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