Device recall
Z-2060-2011: Luxtec MLX 300 Watt Xenon Light Source, Model OOMLX; Surgical/Medical Light…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-2060-2011 |
|---|---|
| Recall event | 58261 |
| Product | Luxtec MLX 300 Watt Xenon Light Source, Model OOMLX; Surgical/Medical Light Source This light source is designed to supply high-intensity light to a fiber optic cable for illumination of a surgical field during a surgical and/or medical procedure. |
| Product code | FCW |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 26, 2014 |
| 510(k) numbers | K081477 |
| FEI number | 3003418325 |
At a glance
- 1–9 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