FDA Device recall Z-1259-2020
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04
- FDA Device
- Class III
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class III recall of HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04 by Advanced Bionics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1259-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-03-18 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Advanced Bionics |
| Distribution | n/a |
Product
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
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.
Identifiers
| code_info | All Lots, UDI (01)07630016832185 Not distributed within the US |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1259-2020%22
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