Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1605-2024.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1605-2024.
Recall ongoing. Follow firm instructions.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Seaspine Orthopedics Corporation or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1605-2024.
SEASPINE ORTHOPEDICS CORPORATION
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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Seaspine Orthopedics Corporation Recall FAQ
Seaspine Orthopedics Corporation is the subject of a medical implants safety report: Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1.... The notice was published on February 15, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 1,579 units are potentially affected.