Device recall
Z-1073-2019: On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X…
FDA device recall · Class II · CryoLife, Inc.
Key facts
| Recall number (Z-number) | Z-1073-2019 |
|---|---|
| Recall event | 82044 |
| Product | On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which consists of an orifice… |
| Product code | LWQ |
| Recalling firm | CryoLife, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 9, 2020 |
| PMA numbers | P000037 |
| FEI number | 3001451326 |
At a glance
- None 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