Device recall
Z-0357-2012: Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXAU Product Usage…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-0357-2012 |
|---|---|
| Recall event | 60300 |
| Product | Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXAU Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through 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 8, 2012 |
| 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