Device recall
Z-2284-2013: Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear…
FDA device recall · Class II · Medtronic Xomed, Inc.
Key facts
| Recall number (Z-number) | Z-2284-2013 |
|---|---|
| Recall event | 66355 |
| Product | Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss. |
| Product code | ETA |
| Recalling firm | Medtronic Xomed, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 7, 2013 |
| 510(k) numbers | K002897 |
| FEI number | 1045254 |
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