Device recall
Z-2646-2017: ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH…
FDA device recall · Class II · Onkos Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-2646-2017 |
|---|---|
| Recall event | 77309 |
| Product | ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E |
| Product code | KRO |
| Recalling firm | Onkos Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 27, 2018 |
| 510(k) numbers | K161520 |
| 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