Z-1259-2020 Class III Terminated
FDA device recall Z-1259-2020 was initiated by Advanced Bionics, LLC on March 18, 2019 and is designated Class III. 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 … The recall status is terminated (terminated April 27, 2021). Affected quantity: 4.
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