FDA recall Z-1259-2020

Product

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

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

Key facts

Status

Terminated

Initiation date

2019-03-18

Report date

2020-02-26

Termination date

2021-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Valencia, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1259-2020