Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Mariner RDX Polyaxial Head Recalled by SEASPINE ORTHOPEDICS CORPORATION Due to Screw heads, of pedicle screw systems, have thin...
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 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 Mariner RDX Alpha Instruments and Implants, REF: AMRDX and Mariner RDX TD Alpha Implants, REF: AMRDXTD, which are pedicle screw systems.
Quantity: 1579 Screw Heads
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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