Class II
Medical Device Recall: Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
SEASPINE ORTHOPEDICS CORPORATION · February 28, 2024
Reason for Recall
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.
Distribution
US: CA, FL, CO, TX
States Affected
CA, CO, FL, TX
Quantity Affected
444 Screw Heads
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1620-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.