Device recall
Z-2194-2011: Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West…
FDA device recall · Class III · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-2194-2011 |
|---|---|
| Recall event | 58490 |
| Product | Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT 84119. A kit for cranial access containing multiple necessary components to create the burr hole which is used to gain access to the cranial vault for the purpose of providing a portal for… |
| Product code | HBG |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 13, 2011 |
| 510(k) numbers | K961113 |
| FEI number | 3003418325 |
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