Mariner RDX recallZ-1605-2024 · Seaspine Orthopedics Corporation · initiated Feb 15, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Seaspine Orthopedics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On 2/14/24 the firm phoned distributors and informed them of the recall issue and next steps. On 2/16/24 the firm sent a recall communication via email. Customers were asked to arrange for the return of these sets along with any additional Mariner RDX inventory using a firm provided return label. Customers with questions or concerns can contact the Associate Product Manager, at [email protected]
Recall details
- Recall number
- Z-1605-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 15, 2024
- Posted by the FDA
- Apr 22, 2024
- Recalling firm
- Seaspine Orthopedics Corporation
- Quantity
- 1579 Screw Heads
- Product code
- NKB
- FDA submissions
- K222110
- Distribution
- US Nationwide distribution in the states of MI, GA, VA, IN, FL.
Product description
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
6 devices in the FDA device registry whose identifier appears in the recall's code information.
- Mariner RDX MX1-000020Seaspine Orthopedics Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000050Seaspine Orthopedics Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
- Mariner RDX MX1-000060Seaspine Orthopedics Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
- Mariner RDX MX1-000070Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K222110 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Mariner RDX MIS MX1-001010Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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