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
|