Device recall
Z-0795-2011: Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model…
FDA device recall · Class II · Advanced Bionics Corporation
Key facts
| Recall number (Z-number) | Z-0795-2011 |
|---|---|
| Recall event | 57349 |
| Product | Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-01 Intended use: The Harmony HiResolution Bionic Ear system is a cochlear implant system designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss. |
| Product code | MCM |
| Recalling firm | Advanced Bionics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 23, 2012 |
| PMA numbers | P960058, P960058S030 |
| 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