Device recall
Z-1699-2014: Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft…
FDA device recall · Class II · Cochlear Americas Inc.
Key facts
| Recall number (Z-number) | Z-1699-2014 |
|---|---|
| Recall event | 68080 |
| Product | Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system. |
| Product code | LXB |
| Recalling firm | Cochlear Americas Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 6, 2014 |
| 510(k) numbers | K131240 |
| FEI number | 3005900820 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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