Device recall
Z-1664-2013: BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold…
FDA device recall · Class II · SpineFrontier, Inc.
Key facts
| Recall number (Z-number) | Z-1664-2013 |
|---|---|
| Recall event | 65432 |
| Product | BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine. |
| Product code | FSM |
| Recalling firm | SpineFrontier, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 17, 2016 |
| 510(k) numbers | K092815 |
| 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