Class III — Advanced Bionics, LLC
| Recalling firm | Advanced Bionics LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | 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. |
| Quantity | 4 |
| Distribution | No US distribution OUS: Japan |
| Initiated | 2019-03-18 |
| Classified | 2020-02-18 |
| Terminated | 2021-04-27 |
| Recall number | Z-1259-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Advanced Bionics, LLC (Z-1259-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84617/
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