HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.

FDA device recall Z-1259-2020 · posted 2020-02-18 · Terminated

Recall details

Recalling firm

Advanced Bionics, LLC

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.

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.

Root cause

Other

Status

Terminated

Product code

MCM

Quantity affected

4

Distribution

No US distribution OUS: Japan

Date initiated

2019-03-18

Date posted

2020-02-18

Date terminated

2021-04-27

Location

Valencia, CA