Device recall
Z-0795-2013: The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under…
FDA device recall · Class I · Lumenis Limited
Key facts
| Recall number (Z-number) | Z-0795-2013 |
|---|---|
| Recall event | 63858 |
| Product | The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited. |
| Product code | GCJ |
| Recalling firm | Lumenis Limited |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 20, 2013 |
| 510(k) numbers | K050639 |
| FEI number | 3004135191 |
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