Recall Z-1259-2020— Advanced Bionics, LLC
Class III · Terminated
Class III FDA medical device recall by Advanced Bionics, LLC, initiated 2019-03-18, terminated 2021-04-27. FDA's recall record names no specific 510(k) clearance for this event. Product: HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.. Reason: 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..
- Recalling firm
- Advanced Bionics, LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-03-18
- Terminated
- 2021-04-27
- Firm location
- Valencia, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.