Device recall
Z-0219-2022: SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated…
FDA device recall · Class II · Cordis Corporation
Key facts
| Recall number (Z-number) | Z-0219-2022 |
|---|---|
| Recall event | 88821 |
| Product | SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree. |
| Product code | FGE |
| Recalling firm | Cordis Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K121125 |
| FEI number | 1016427 |
At a glance
- 1–9 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