Device recall
Z-0414-2013: The brand name of the device is Laser Loupes, a dentalloupe with laser eye…
FDA device recall · Class II · Kerr Corporation
Key facts
| Recall number (Z-number) | Z-0414-2013 |
|---|---|
| Recall event | 63516 |
| Product | The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each colored filter is… |
| Product code | FSP |
| Recalling firm | Kerr Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 21, 2012 |
| FEI number | 3003848022 |
At a glance
- None 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