Device recall
Z-1213-2012: SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary…
FDA device recall · Class II · Idev Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-1213-2012 |
|---|---|
| Recall event | 61090 |
| Product | SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms. |
| Product code | FGE |
| Recalling firm | Idev Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 9, 2013 |
| 510(k) numbers | K093893 |
| FEI number | 3005325609 |
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