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Recall Observatory FDA recall evidence

Device 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.

Z-1620-2024

February 28, 2024

Class II

Product summary

Firm
SEASPINE ORTHOPEDICS CORPORATION
Event
Event 94306
Status
Ongoing
Classification
Class II
Quantity
444 Screw Heads
Official record key
device-enforcement:Z-1620-2024

Official wording

Reason: 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.

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

Distribution pattern: US: CA, FL, CO, TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.