Device recall
Z-1355-2020: Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-1355-2020 |
|---|---|
| Recall event | 84778 |
| Product | Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft. |
| Product code | MIH |
| Recalling firm | Cook Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 12, 2020 |
| 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