Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1620-2024.
Screw heads, of pedicle screw systems, have partial thread within the screw head 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-1620-2024.
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-1620-2024.
SEASPINE ORTHOPEDICS CORPORATION
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Seaspine Orthopedics Corporation Recall FAQ
Seaspine Orthopedics Corporation is the subject of a medical implants safety report: Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle.... The notice was published on February 28, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 444 units are potentially affected.