Device recall
Z-1620-2024: Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha…
FDA device recall · Class II · SEASPINE ORTHOPEDICS CORPORATION
Key facts
| Recall number (Z-number) | Z-1620-2024 |
|---|---|
| Recall event | 94306 |
| Product | Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems. |
| Product code | NKB |
| Recalling firm | SEASPINE ORTHOPEDICS CORPORATION |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K222110 |
| FEI number | 3012120772 |
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