Device recall
Z-3135-2011: Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-30-82-ZT…
FDA device recall · Class III · Cook, Inc.
Key facts
| Recall number (Z-number) | Z-3135-2011 |
|---|---|
| Recall event | 58613 |
| Product | Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-30-82-ZT, REF G48422, 20 Fr ID/ 7.7 mm OD |
| Product code | MIH |
| Recalling firm | Cook, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 13, 2011 |
| PMA numbers | P020018 |
| FEI number | 1820334 |
At a glance
- None Linked 510(k)s
- 10–99 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