Device recall
Z-2988-2011: Direct Drive Grasper, VARIOUS KITS CONTAINING EITHER C4130 OR C4140 Intended…
FDA device recall · Class II · Applied Medical Resources Corp
Key facts
| Recall number (Z-number) | Z-2988-2011 |
|---|---|
| Recall event | 59367 |
| Product | Direct Drive Grasper, VARIOUS KITS CONTAINING EITHER C4130 OR C4140 Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrument is not intended for use when minimally invasive techniques are contraindicated. Complications which… |
| Product code | GCJ |
| Recalling firm | Applied Medical Resources Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 26, 2012 |
| FEI number | 2027111 |
At a glance
- None 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