Device recall
Z-1933-2013: Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion…
FDA device recall · Class II · SpineFrontier, Inc.
Key facts
| Recall number (Z-number) | Z-1933-2013 |
|---|---|
| Recall event | 65653 |
| Product | Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that… |
| Product code | FSM |
| Recalling firm | SpineFrontier, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 11, 2016 |
| 510(k) numbers | K121060 |
| FEI number | 3005977257 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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