Device recall
Z-0339-2014: Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura…
FDA device recall · Class II · Synovis Surgical Innovations, Inc.
Key facts
| Recall number (Z-number) | Z-0339-2014 |
|---|---|
| Recall event | 66763 |
| Product | Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure of dura mater during neurosurgery. Product Code: DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN… |
| Product code | GXQ |
| Recalling firm | Synovis Surgical Innovations, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 3, 2014 |
| 510(k) numbers | K982282 |
| FEI number | 2183620 |
At a glance
- 1–9 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