Device recall
Z-2187-2013: StaXx IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion…
FDA device recall · Class II · Spine Wave, Inc.
Key facts
| Recall number (Z-number) | Z-2187-2013 |
|---|---|
| Recall event | 65968 |
| Product | StaXx IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients. |
| Product code | MAX |
| Recalling firm | Spine Wave, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 10, 2014 |
| 510(k) numbers | K123461 |
| FEI number | 3004638600 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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