Device recall
Z-1605-2024: Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial…
FDA device recall · Class II · SEASPINE ORTHOPEDICS CORPORATION
Key facts
| Recall number (Z-number) | Z-1605-2024 |
|---|---|
| Recall event | 94164 |
| Product | Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX Extended Deformity Head, REF: MX1-000050; Mariner RDX Trauma Head, REF: MX1-000060; Mariner RDX Extended Trauma Head. REF: MX1-000070, part of… |
| 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