Device recall
Z-0876-2013: Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX…
FDA device recall · Class III · Ultradent Products, Inc.
Key facts
| Recall number (Z-number) | Z-0876-2013 |
|---|---|
| Recall event | 64303 |
| Product | Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets. |
| Product code | EJF |
| Recalling firm | Ultradent Products, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 7, 2013 |
| 510(k) numbers | K922499 |
| FEI number | 1718912 |
At a glance
- 1–9 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