HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
- Company
- Advanced Bionics, Llc
- Recall Initiated
- March 18, 2019
- Posted
- February 18, 2020
- Terminated
- April 27, 2021
- Recall Number
- Z-1259-2020
- Quantity
- 4
- Firm Location
- Valencia, CA
Reason for Recall
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.
Distribution
No US distribution OUS: Japan
Lot / Code Info
All Lots, UDI (01)07630016832185 Not distributed within the US
Root Cause
Other
Action Taken
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.