Device recall
Z-0967-2011: StaXx XD Expandable Cartridge Convex Expandable Implant 25mm (L) x 9mm (W) x 7mm…
FDA device recall · Class II · Spine Wave Inc
Key facts
| Recall number (Z-number) | Z-0967-2011 |
|---|---|
| Recall event | 57188 |
| Product | StaXx XD Expandable Cartridge Convex Expandable Implant 25mm (L) x 9mm (W) x 7mm (H) Catalog number: 11-1525 The StaXx XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral… |
| Recalling firm | Spine Wave Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 15, 2011 |
| 510(k) numbers | K101288 |
| FEI number | 3004638600 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
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