Device recall
Z-1279-2012: Codman ICP Skull Bolt Kit, Product Code: 82-6638. Single Use, disposable drill…
FDA device recall · Class II · Codman & Shurtleff, Inc.
Key facts
| Recall number (Z-number) | Z-1279-2012 |
|---|---|
| Recall event | 61205 |
| Product | Codman ICP Skull Bolt Kit, Product Code: 82-6638. Single Use, disposable drill kit for gaining access to the cranium to allow for insertion and retention of intracranial cranial pressure sensor, included in the kit. |
| Product code | GWM |
| Recalling firm | Codman & Shurtleff, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 11, 2015 |
| 510(k) numbers | K974088 |
| 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