Reported May 1, 2024 · Ongoing
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS,…
Seaspine Orthopedics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SEASPINE ORTHOPEDICS CORPORATION · 5770 Armada Dr · Carlsbad, CA · 92008-4608
Is this the product you have?
- Mariner RDX MIS Polyaxial Head
- REFMX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants
- REFAMRDXMIS, which are pedicle screw systems
- Lot codes and dates
- REF/UDI-DI/LotsMX1-001010/10889981298647/ AW161319D, AW164195D, AW166994D, AW167309D, AW167422D, AW169350F, AW169351F. AMRDXMIS/10889981303297/ AMRDXMIS-001, AMRDXMIS-002, AMRDXMIS-003, AMRDXMIS-004, AMRDXMIS-005
- Amount recalled
- 444 Screw Heads
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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