Advanced Bionics, LLC: Medical Device Recall in 2020 - (Recall #: Z-1259-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: March 18, 2019

Date Posted: February 26, 2020

Recall Number: Z-1259-2020

Event ID: 84617

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.

Status: Terminated

Product Quantity: 4

Code Information:

All Lots, UDI (01)07630016832185 Not distributed within the US

Distribution Pattern:

No US distribution OUS: Japan

Voluntary or Mandated:

Voluntary: Firm initiated