Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of… recallZ-1620-2024 · Seaspine Orthopedics Corporation · initiated Feb 28, 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 partial thread within the screw head 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 2/26/24, the firm phoned customers and informed them of the recall and that they would receive an email outlining details of the field action and subsequent steps to be taken. On 2/28/24, recall emails were sent to customers asking customers to respond to the emails to coordinate product return and replacement. Customers with questions can contact the firm at [email protected].
Recall details
- Recall number
- Z-1620-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 28, 2024
- Posted by the FDA
- Apr 23, 2024
- Recalling firm
- Seaspine Orthopedics Corporation
- Quantity
- 444 Screw Heads
- Product code
- NKB
- FDA submissions
- K222110
- Distribution
- US: CA, FL, CO, TX
Product description
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Mariner RDX MIS MX1-001010Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
Other devices under the same FDA submission
6 devices 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 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
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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