Device recall
Z-0481-2014: Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2…
FDA device recall · Class III · Ultradent Products, Inc.
Key facts
| Recall number (Z-number) | Z-0481-2014 |
|---|---|
| Recall event | 66978 |
| Product | Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment. |
| Product code | NJM |
| Recalling firm | Ultradent Products, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 6, 2014 |
| FEI number | 1718912 |
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