Device recall
Z-0379-2012: Mark II Headlight module-black Model: 001380LX Product Usage: The fiber optic…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-0379-2012 |
|---|---|
| Recall event | 60214 |
| Product | Mark II Headlight module-black Model: 001380LX Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination. |
| Product code | FST |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 1, 2012 |
| FEI number | 3003418325 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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