Device recall
Z-0756-2012: 31144 Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt…
FDA device recall · Class II · Integra LifeSciences Corp. d.b.a. Integra Pain Management
Key facts
| Recall number (Z-number) | Z-0756-2012 |
|---|---|
| Recall event | 60798 |
| Product | 31144 Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP, 1 CSF Drainage System, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage: The Xylocaine component of the kit is… |
| Product code | HBG |
| Recalling firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 10, 2012 |
| 510(k) numbers | K961113 |
| FEI number | 1000138491 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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