Reported May 1, 2024 · Ongoing
Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX…
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?
6 products · 24 lot codes
MX1-000020Mariner RDX Polyaxial Head
- UDI-DI
10889981289751
5 recalled lot codes
AW161073CAW164798DAW164799DAW164800EAW164801E
MX1-000030Mariner RDX Extended Polyaxial Head
- UDI-DI
10889981289768
5 recalled lot codes
AW164802FAW164803GAW157588FAW161074FAW163331F
MX1-000040Mariner RDX Deformity Head
- UDI-DI
10889981289775
2 recalled lot codes
AW157589DAW164806E
MX1-000050Mariner RDX Extended Deformity Head
- UDI-DI
10889981289782
5 recalled lot codes
AW164807GAW164808GAW164809HAW157590GAW172902H
Page 1 of 2
- Amount recalled
- 1579 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 thin lead-in thread 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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