Home / Recalls / Medical Devices
SEASPINE ORTHOPEDICS CORPORATION recalls Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformi
Recalled May 1, 2024 · FDA recall Z-1605-2024 · SEASPINE ORTHOPEDICS
Hazard
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. · FDA Class II
Units
1579 Screw Heads
Sold at
US Nationwide distribution in the states of MI, GA, VA, IN, FL.
Description
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.
Product
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.
Manufacturer(s)
SEASPINE ORTHOPEDICS CORPORATION
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →