Date Initiated by Firm | March 18, 2019 |
Date Posted | February 18, 2020 |
Recall Status1 |
Terminated 3 on April 27, 2021 |
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 |
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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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PMA Database | PMAs with Product Code = MCM
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