Device recall
Z-0137-2014: Surgicutt fully automated incision making device for bleeding time…
FDA device recall · Class II · ITC-Nexus Dx
Key facts
| Recall number (Z-number) | Z-0137-2014 |
|---|---|
| Recall event | 66353 |
| Product | Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm… |
| Product code | JCA |
| Recalling firm | ITC-Nexus Dx |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 9, 2014 |
| FEI number | 2250033 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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