Device recall
Z-0861-2014: Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device…
FDA device recall · Class II · Codman & Shurtleff, Inc.
Key facts
| Recall number (Z-number) | Z-0861-2014 |
|---|---|
| Recall event | 65179 |
| Product | Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of… |
| Product code | JXG |
| Recalling firm | Codman & Shurtleff, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 2, 2015 |
| 510(k) numbers | K112156, K113526 |
| FEI number | 3002947440 |
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