CLASS II ONGOING Device recall · Reported 1 May 2024 · FDA Enforcement Report

Mariner RDX MIS Polyaxial Head recalled by Seaspine Orthopedics

Seaspine Orthopedics is recalling Mariner RDX MIS Polyaxial Head, distributed in California, Colorado, Florida, Texas. The recall was initiated on 28 Feb 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF/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

Quantity recalled444 Screw Heads

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1620-2024
FDA event ID: 94306
Recalling firm: Seaspine Orthopedics, Carlsbad, CA
Classification: Class II
Status: Ongoing
Recall initiated: 28 Feb 2024
FDA classified: 23 Apr 2024
Reported: 1 May 2024
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

28 Feb 2024	Recall initiated by company
23 Apr 2024	Classified by FDA	+55 days
1 May 2024	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.

Where it was distributed

US: CA, FL, CO, TX

California Colorado Florida Texas

Questions about this recall

Is Mariner RDX MIS Polyaxial Head recalled?

Yes. Seaspine Orthopedics recalled Mariner RDX MIS Polyaxial Head on 28 Feb 2024. The recall is Class II and its status is Ongoing. Recall number Z-1620-2024.

Why was it 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.

Which lots are affected?

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

Where was it sold?

US: CA, FL, CO, TX

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Seaspine Orthopedics

All 10

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	SeaSpine Polyaxial Head recalled by Seaspine Orthopedics	Seaspine Orthopedics	Other	Nationwide
24 Dec 2025Device	CLASS II	Orthofix NorthStar OCT Navigation Surgical Technique Guide recalled	Seaspine Orthopedics	Lead & Heavy Metals	24 states
17 Sep 2025Device	CLASS II	Reef TA Inserter recalled by Seaspine Orthopedics	Seaspine Orthopedics	Lead & Heavy Metals	Nationwide
1 Jan 2025Device	CLASS II	Daytona Small Stature Ti Locking Cap, Small Stature, T25 recalled	Seaspine Orthopedics	Device Malfunction	Nationwide
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