Device recall
Z-3178-2026: Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF…
FDA device recall · Class II · restor3d Inc.
Key facts
| Recall number (Z-number) | Z-3178-2026 |
|---|---|
| Recall event | 99512 |
| Product | Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006 |
| Product code | OYK |
| Recalling firm | restor3d Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K223326 |
| FEI number | 3014833750 |
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