Advanced Bionics, LLC recalls HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocu
Recalled Product
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Hazard / Issue
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.
Issued by
FDA
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