Device recall
Z-0117-2013: HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution…
FDA device recall · Class II · Advanced Bionics Corporation
Key facts
| Recall number (Z-number) | Z-0117-2013 |
|---|---|
| Recall event | 63353 |
| Product | HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe to profound hearing loss. It consists of internal and external components. The internal components include a… |
| Product code | MCM |
| Recalling firm | Advanced Bionics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 22, 2012 |
| 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