Device recall
Z-2425-2025: ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED…
FDA device recall · Class II · Onkos Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-2425-2025 |
|---|---|
| Recall event | 97343 |
| Product | ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants. |
| Product code | JDI |
| Recalling firm | Onkos Surgical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K161520, K203588 |
| FEI number | 3013450937 |
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