Device recall
Z-0117-2025: The Graft Tube is an optional instrument which, as designed, can be filled with…
FDA device recall · Class II · Spineology, Inc.
Key facts
| Recall number (Z-number) | Z-0117-2025 |
|---|---|
| Recall event | 95341 |
| Product | The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A Push Rod is then used to facilitate the manual deployment of the graft material out of the Graft Tube and adjacent to where the implant is to be placed… |
| Product code | LXH |
| Recalling firm | Spineology, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3003179719 |
At a glance
- None 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