Device recall
Z-0759-06: The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured…
FDA device recall · Class II · Advanced Bionics Corporation
Key facts
| Recall number (Z-number) | Z-0759-06 |
|---|---|
| Recall event | 34873 |
| Product | The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a specific supplier are being removed from the market. Model number CI-1400-02H. |
| Product code | MCM |
| Recalling firm | Advanced Bionics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 23, 2012 |
| 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