FDAFDA · Food and drugs·Recall number Z-1620-2024
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
Published May 1, 2024 · Recall initiated: February 28, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Distributor
- US: CA, FL, CO, TX
- Lot
- REF/UDI-DI/Lots: MX1-001010/10889981298647/ AW161319D, AW164195D, AW166994D, AW167309D, AW167422D, AW169350F, AW169351F. AMRDXMIS/10889981303297/ AMRDXMIS-001, AMRDXMIS-002, AMRDXMIS-003, AMRDXMIS-004, AMRDXMIS-005
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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