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Terminated

HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.

FDA Recall Z-1259-2020 · Posted 2020-02-18

Recalling FirmAdvanced Bionics, LLC
Recall StatusTerminated
Product CodeMCM
Date Initiated2019-03-18
Date Terminated2021-04-27
Product Quantity4

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.

Firm 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.

Root Cause

Other

Distribution Pattern

No US distribution OUS: Japan

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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