Device recall
Z-1616-2024: Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the…
FDA device recall · Class II · EBI, LLC
Key facts
| Recall number (Z-number) | Z-1616-2024 |
|---|---|
| Recall event | 94291 |
| Product | Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716 |
| Product code | LOF |
| Recalling firm | EBI, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P850022 |
| FEI number | 2242816 |
At a glance
- None 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