Device recall
Z-1507-2015: HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21…
FDA device recall · Class II · Specialty Appliance Works, Inc.
Key facts
| Recall number (Z-number) | Z-1507-2015 |
|---|---|
| Recall event | 70787 |
| Product | HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24 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