Device recall
Z-1177-2025: Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer…
FDA device recall · Class II · XTANT Medical Holdings, Inc
Key facts
| Recall number (Z-number) | Z-1177-2025 |
|---|---|
| Recall event | 96179 |
| Product | Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8, 19mm, PC, (STERILE)) |
| Product code | OVD |
| Recalling firm | XTANT Medical Holdings, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K171567 |
| FEI number | 3005031160 |
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