Device recall
Z-1259-2020: HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF…
FDA device recall · Class III · Advanced Bionics, LLC
Key facts
| Recall number (Z-number) | Z-1259-2020 |
|---|---|
| Recall event | 84617 |
| Product | HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant. |
| Product code | MCM |
| Recalling firm | Advanced Bionics, LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 27, 2021 |
| 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