Advanced Bionics, LLC recalls HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
- Recall date
- March 18, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1259-2020
- FDA classification
- Class III
- Brand / firm
- Advanced Bionics, LLC
- Sold / distributed
- No US distribution OUS: Japan
Why it was recalled
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.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
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