Device product
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Z-1259-2020
Product summary
- Event
- Event 84617
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4
- Official record key
device-enforcement:Z-1259-2020
Official wording
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.
Code information: All Lots, UDI (01)07630016832185 Not distributed within the US
Distribution pattern: No US distribution OUS: Japan
Derived failure modes
-
Unknown
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.