Device recall
Z-2546-2020: Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-2546-2020 |
|---|---|
| Recall event | 85805 |
| Product | Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair. |
| Product code | MIH |
| Recalling firm | Cook Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 5, 2022 |
| FEI number | 1820334 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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