Device recall
Z-0313-2011: microTargeting Drive DBS Lead Holder 66-CN-DB Product is the FHC DBS Depth Stop…
FDA device recall · Class II · FHC, Inc.
Key facts
| Recall number (Z-number) | Z-0313-2011 |
|---|---|
| Recall event | 55287 |
| Product | microTargeting Drive DBS Lead Holder 66-CN-DB Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning… |
| Product code | HAW |
| Recalling firm | FHC, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 25, 2015 |
| 510(k) numbers | K003776 |
| FEI number | 3002250546 |
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