Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Mariner RDX MIS Polyaxial Head Recalled by SEASPINE ORTHOPEDICS CORPORATION Due to Screw heads, of pedicle screw systems, have partial...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SEASPINE ORTHOPEDICS CORPORATION directly.
Affected Products
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
Quantity: 444 Screw Heads
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 4 states: CA, CO, FL, TX
About SEASPINE ORTHOPEDICS CORPORATION
SEASPINE ORTHOPEDICS CORPORATION has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report