Device recall
Z-1511-2015: TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC…
FDA device recall · Class II · Specialty Appliance Works, Inc.
Key facts
| Recall number (Z-number) | Z-1511-2015 |
|---|---|
| Recall event | 70787 |
| Product | TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown… |
| 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