Device recall
Z-0046-05: Advanced Bionics implantable cochlear stimulator HiRes 90, Models CI-1400-01…
FDA device recall · Class II · Advanced Bionics
Key facts
| Recall number (Z-number) | Z-0046-05 |
|---|---|
| Recall event | 30209 |
| Product | Advanced Bionics implantable cochlear stimulator HiRes 90, Models CI-1400-01 CI-1400-02 |
| Product code | MCM |
| Recalling firm | Advanced Bionics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 13, 2005 |
| 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