Home / Recalls / Advanced Bionics, LLC / Z-1259-2020

Z-1259-2020 Class III Terminated

Recalled by Advanced Bionics, LLC — Valencia, CA

Recall Details

Product Type
Devices
Report Date
February 26, 2020
Initiation Date
March 18, 2019
Termination Date
April 27, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4

Product Description

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 Pattern

No US distribution OUS: Japan

Code Information

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

Other recalls by Advanced Bionics, LLC

  • Z-1493-2026 Class II — Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Proce (November 27, 2025)
  • Z-1813-2025 Class II — HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 (March 5, 2025)
  • Z-0487-2021 Class III — AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used (September 26, 2020)
  • Z-0486-2021 Class III — AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used (September 26, 2020)
  • Z-2032-2020 Class II — AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - (February 17, 2020)
  • Z-2033-2020 Class II — AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: (February 17, 2020)
  • Z-1441-2020 Class III — SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, U (April 4, 2019)
  • Z-1085-2019 Class II — Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140. (February 6, 2019)
  • Z-1083-2019 Class II — Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model (February 6, 2019)
  • Z-1084-2019 Class II — Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model (February 6, 2019)