Device recall
Z-2039-2009: Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H…
FDA device recall · Class II · Advanced Bionics LLC
Key facts
| Recall number (Z-number) | Z-2039-2009 |
|---|---|
| Recall event | 52700 |
| Product | Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case. Cochlear implant 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 | Mar 26, 2012 |
| PMA numbers | P960058 |
| FEI number | 3006556115 |
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