Device recall
Z-0583-2016: InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and…
FDA device recall · Class II · Ultradent Products, Inc.
Key facts
| Recall number (Z-number) | Z-0583-2016 |
|---|---|
| Recall event | 72814 |
| Product | InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel preparations as well as air… |
| Product code | DZN |
| Recalling firm | Ultradent Products, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 19, 2016 |
| 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