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SEASPINE ORTHOPEDICS CORPORATION recalls Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS,
Recalled May 1, 2024 · FDA recall Z-1620-2024 · SEASPINE ORTHOPEDICS
Hazard
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. · FDA Class II
Units
444 Screw Heads
Sold at
US: CA, FL, CO, TX
Description
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.
Product
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
Manufacturer(s)
SEASPINE ORTHOPEDICS CORPORATION
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →