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U.S. Department of Health and Human Services

Class 3 Device Recall HiResolution Bionic Ear System

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  Class 3 Device Recall HiResolution Bionic Ear System see related information
Date Initiated by Firm March 18, 2019
Create Date February 18, 2020
Recall Status1 Completed
Recall Number Z-1259-2020
Recall Event ID 84617
PMA Number P960058 
Product Classification Implant, cochlear - Product Code MCM
Product HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Code Information All Lots, UDI (01)07630016832185  Not distributed within the US
Recalling Firm/
Manufacturer
Advanced Bionics, LLC
28515 Westinghouse Pl
Valencia CA 91355-1398
For Additional Information Contact Ms. Carol Abernathy
661-362-7580
Manufacturer Reason
for Recall
Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
FDA Determined
Cause 2
Other
Action On March 18, 2019, the firm sent a "Voluntary Field Action" letter was sent to Japanese surgeons who implanted the device. The firm has stopped sales until the documentation is finalized. The field action letter informed customers that the action was due to an error in documentation and poses no risk to patient safety. The serial numbers of implanted HiRes90K Advantage cochlear implants with 1J and MS electrodes will be made available on the PMDA website.
Quantity in Commerce 4
Distribution No US distribution OUS: Japan
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.
PMA Database PMAs with Product Code = MCM and Original Applicant = ADVANCED BIONICS
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