Z-1620-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2024
- Initiation Date
- February 28, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 444 Screw Heads
Product Description
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
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 Pattern
US: CA, FL, CO, TX
Code Information
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