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Advanced Bionics, LLC recalls HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Recalled February 26, 2020 · FDA recall Z-1259-2020 · Advanced Bionics
Hazard
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 Class III
Units
4
Sold at
No US distribution OUS: Japan
Description
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.
Product
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Manufacturer(s)
Advanced Bionics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →