Recall Z-1259-2020 ยท MCM Implant, Cochlear
Advanced Bionics, LLC
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
| Date | Feb 18, 2020 (initiated Mar 18, 2019) |
| 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. |
| Root cause | Other |
| Action | On March 18, 2019, the firm sent a "Voluntary Field Action" letter was sent to Japanese surgeons who implanted the device. The firm has stopped sales until the documentation is finalized. The field action letter informed customers that the action was due to an error in documentation and poses no risk to patient safety. The serial numbers of implanted HiRes90K Advantage cochlear implants with 1J and MS electrodes will be made available on the PMDA website. |
| Quantity | 4 |
| Distribution | No US distribution OUS: Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.