Device recall
Z-0268-2013: The brand name of the device is AlgiNot, a dental impression material. Product…
FDA device recall · Class II · Kerr Corporation
Key facts
| Recall number (Z-number) | Z-0268-2013 |
|---|---|
| Recall event | 63297 |
| Product | The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for… |
| Product code | ELW |
| Recalling firm | Kerr Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 15, 2012 |
| 510(k) numbers | K050604 |
| FEI number | 1815757 |
At a glance
- 1–9 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