Drug recall
Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX…
FDA recall event 94164 · Class II · SEASPINE ORTHOPEDICS CORPORATION
Key facts
| Event ID | 94164 |
|---|---|
| Recall numbers | Z-1605-2024 |
| Recalling firm | SEASPINE ORTHOPEDICS CORPORATION |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface. |
| Initiation date | Feb 15, 2024 |
| Report date | May 1, 2024 |
| City | Carlsbad |
| State | CA |
| Country | United States |
| FEI number | 3012120772 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: