SEASPINE Mariner RDX MIS Polyaxial Head Recall: Risk of Intraoperative Cross-Threaded
SEASPINE recalls Mariner RDX MIS Polyaxial Heads (REF MX1-00101: 10889981298647) with partial thread risk causing cross-threading during surgery. Affected units include specific model lots and serial numbers.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
SEASPINE is recalling Mariner RDX MIS Polyaxial Heads that have partial threads in the screw heads. This can cause cross-threading during surgery, potentially leading to complications if the locking cap and screw head interface fails. Read more at govinfonow.com/recall/56036-seaspine-mariner-rdx-mis-polyaxial-head-recall-risk-of-intraoperative.
Source Summary by GovInfoNow · govinfonow.com/recall/56036-seaspine-mariner-rdx-mis-polyaxial-head-recall-risk-of-intraoperative · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1620-2024
Cite this page
“SEASPINE Mariner RDX MIS Polyaxial Head Recall: Risk of Intraoperative Cross-Threaded.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56036-seaspine-mariner-rdx-mis-polyaxial-head-recall-risk-of-intraoperative. Based on FDA recall #Z-1620-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1620-2024%22&limit=1).
Why it’s dangerous
The screw heads have partial threads that can cause cross-threading between the locking cap and screw head during surgery. This may lead to improper implant fixation, increasing the risk of complications like instability or misalignment.
Who’s affected
Orthopedic surgeons and medical professionals using the Mariner RDX MIS Polyaxial Heads for spinal surgery are most at risk. Patients receiving these implants may also be affected if the device is used improperly.
How to tell if you have this one
Check for the reference number MX1-001010 on the product. Affected units include specific model lots and serial numbers listed in the recall notice.
- Brand
SEASPINE- Category
Medical device
What to do — step by step
Check Product Details
Review the reference number on the product to confirm if it matches the listed lots and serial numbers.
Where it went and when
Where it was distributed
Distributed in 4 states.
FDA distribution: “US: CA, FL, CO, TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Florida, Texas.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1620-2024 (February 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1620-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.