Device recall
Z-0551-2014: Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial…
FDA device recall · Class II · Integra LifeSciences Corp. d.b.a. Integra Pain Management
Key facts
| Recall number (Z-number) | Z-0551-2014 |
|---|---|
| Recall event | 66949 |
| Product | Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in selected patients to reduce… |
| Product code | JXG |
| Recalling firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 9, 2014 |
| 510(k) numbers | K042359 |
| FEI number | 1000138491 |
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