Device recall
Z-2155-2015: Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus…
FDA device recall · Class II · Cochlear Americas Inc.
Key facts
| Recall number (Z-number) | Z-2155-2015 |
|---|---|
| Recall event | 71509 |
| Product | Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes |
| Product code | MCM |
| Recalling firm | Cochlear Americas Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 5, 2015 |
| 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