Device recall
Z-0533-2022: X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
FDA device recall · Class II · XTANT Medical
Key facts
| Recall number (Z-number) | Z-0533-2022 |
|---|---|
| Recall event | 89367 |
| Product | X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. |
| Product code | PEK |
| Recalling firm | XTANT Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 17, 2024 |
| 510(k) numbers | K130438 |
| FEI number | 3005031160 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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