CLASS II ONGOING Device recall · Reported 1 May 2024 · FDA Enforcement Report
Mariner RDX Polyaxial Head recalled by Seaspine Orthopedics
Seaspine Orthopedics is recalling Mariner RDX Polyaxial Head, distributed nationwide in the US. The recall was initiated on 15 Feb 2024 and the FDA has classified it as Class II.
Check your package
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-1605-2024
- FDA event ID
- 94164
- Recalling firm
- Seaspine Orthopedics, Carlsbad, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Feb 2024
- FDA classified
- 22 Apr 2024
- Reported
- 1 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Spinal Implants
Timeline
| 15 Feb 2024 | Recall initiated by company | |
| 22 Apr 2024 | Classified by FDA | +67 days |
| 1 May 2024 | Published in enforcement report | +9 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 thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX Extended Deformity Head, REF: MX1-000050; Mariner RDX Trauma Head, REF: MX1-000060; Mariner RDX Extended Trauma Head. REF: MX1-000070, part of Mariner RDX Alpha Instruments and Implants, REF: AMRDX and Mariner RDX TD Alpha Implants, REF: AMRDXTD, which are pedicle screw systems.
Where it was distributed
US Nationwide distribution in the states of MI, GA, VA, IN, FL.
Questions about this recall
Is Mariner RDX Polyaxial Head recalled?
Yes. Seaspine Orthopedics recalled Mariner RDX Polyaxial Head on 15 Feb 2024. The recall is Class II and its status is Ongoing. Recall number Z-1605-2024.
Why was it 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.
Which lots are affected?
REF/UDI-DI/Lots: MX1-000020/10889981289751/AW161073C, AW164798D, AW164799D, AW164800E, AW164801E; MX1-000030/10889981289768/AW164802F, AW164803G, AW157588F, AW161074F, AW163331F; MX1-000040/10889981289775/AW157589D, AW164806E; MX1-000050/10889981289782/AW164807G, AW164808G, AW164809H, AW157590G, AW172902H; MX1-000060/10889981289799/AW157591D, AW161076E, AW164811E; MX1-000070/10889981289805/AW163350G, AW164812G, AW157592G, AW161077G; AMRDX/10889981291266/AMRDX-001, AMRDX-002, AMRDX-003, AMRDX-004, AMRDX-005, AMRDX-008, AMRDX-009; AMRDXTD/10889981295332/AMRDXTD-003, AMRDXTD-004, AMRDXTD-005
Where was it sold?
US Nationwide distribution in the states of MI, GA, VA, IN, FL.
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 |
|---|---|---|---|---|---|
| Device | CLASS II | SeaSpine Polyaxial Head recalled by Seaspine Orthopedics | Seaspine Orthopedics | Other | Nationwide |
| Device | CLASS II | Orthofix NorthStar OCT Navigation Surgical Technique Guide recalled | Seaspine Orthopedics | Lead & Heavy Metals | 24 states |
| Device | CLASS II | Reef TA Inserter recalled by Seaspine Orthopedics | Seaspine Orthopedics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Daytona Small Stature Ti Locking Cap, Small Stature, T25 recalled | Seaspine Orthopedics | Device Malfunction | Nationwide |
| Device | CLASS II | Daytona Small Stature CoCr LockingCap, Small Stature, T25, BT recalled | Seaspine Orthopedics | Device Malfunction | Nationwide |
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