Recall Z-2033-2020— Advanced Bionics, LLC
Class II · Terminated
Class II FDA medical device recall by Advanced Bionics, LLC, initiated 2020-02-17, terminated 2023-01-26. FDA's recall record names no specific 510(k) clearance for this event. Product: AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.. Reason: hearing performance degradation due to body-fluid entering the device..
- Recalling firm
- Advanced Bionics, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-17
- Terminated
- 2023-01-26
- Firm location
- Valencia, CA, United States
Product description
AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
Reason for recall
hearing performance degradation due to body-fluid entering the device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.