Device recall
Z-3108-2017: On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated…
FDA device recall · Class II · CryoLife, Inc.
Key facts
| Recall number (Z-number) | Z-3108-2017 |
|---|---|
| Recall event | 77728 |
| Product | On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease. |
| Product code | NPT |
| Recalling firm | CryoLife, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 5, 2019 |
| PMA numbers | P000037 |
| FEI number | 3001451326 |
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