Device recall
Z-1556-2008: CORDIS S.M.A.R.T. Control" Nitinol Stent System Model Number(s): C10040SL…
FDA device recall · Class II · Cordis Corporation
Key facts
| Recall number (Z-number) | Z-1556-2008 |
|---|---|
| Recall event | 47347 |
| Product | CORDIS S.M.A.R.T. Control" Nitinol Stent System Model Number(s): C10040SL, Manufactured in Mexico. Indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease. |
| Product code | NIO |
| Recalling firm | Cordis Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 1, 2009 |
| PMA numbers | P020036 |
| FEI number | 1016427 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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