Device recall
Z-0003-2012: Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5…
FDA device recall · Class II · Cochlear Americas Inc.
Key facts
| Recall number (Z-number) | Z-0003-2012 |
|---|---|
| Recall event | 59979 |
| Product | Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve. |
| Product code | MCM |
| Recalling firm | Cochlear Americas Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 10, 2012 |
| PMA numbers | P970051 |
| FEI number | 3005900820 |
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