Device recall
Z-1503-2015: MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient…
FDA device recall · Class II · Specialty Appliance Works, Inc.
Key facts
| Recall number (Z-number) | Z-1503-2015 |
|---|---|
| Recall event | 70787 |
| Product | MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance. |
| Product code | ECN |
| Recalling firm | Specialty Appliance Works, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 12, 2017 |
| FEI number | 3004158247 |
At a glance
- None Linked 510(k)s
- 10–99 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