Device recall
Z-2128-2014: Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50…
FDA device recall · Class II · Novocol, Inc.
Key facts
| Recall number (Z-number) | Z-2128-2014 |
|---|---|
| Recall event | 68794 |
| Product | Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert. |
| Product code | KLE |
| Recalling firm | Novocol, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 31, 2014 |
| 510(k) numbers | K042614 |
| FEI number | 1721729 |
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