Device recall
Z-0706-2012: Codman Cranial Access Kit with Xylocaine Product Code: 82-6612 Product Usage…
FDA device recall · Class II · Codman & Shurtleff, Inc.
Key facts
| Recall number (Z-number) | Z-0706-2012 |
|---|---|
| Recall event | 60362 |
| Product | Codman Cranial Access Kit with Xylocaine Product Code: 82-6612 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures. |
| Product code | GWM |
| Recalling firm | Codman & Shurtleff, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 29, 2015 |
| 510(k) numbers | K914479 |
| FEI number | 3002947440 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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