Device recall
Z-2032-2020: AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode…
FDA device recall · Class II · Advanced Bionics, LLC
Key facts
| Recall number (Z-number) | Z-2032-2020 |
|---|---|
| Recall event | 85141 |
| Product | AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ 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. |
| Product code | MCM |
| Recalling firm | Advanced Bionics, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 26, 2023 |
| PMA numbers | P960058 |
| FEI number | 1000220815 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database