Mariner RDX Pedicle Screws Risk Cross-Threading During Surgery
SEASPINE recalls specific pedicle screw models due to thin thread design that may cause cross-threading during surgery, potentially leading to complications. Affected models include Mariner RDX Polyaxial and Extended Polyaxial Heads with reference numbers MX1-000020 to MX1-000070.
Recall notice
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.
Contact the company
What happened, in plain English
SEASPINE is recalling certain pedicle screw models that have a thin thread design which can cause cross-threading during surgery. This risk could lead to complications if the screws are used incorrectly in spinal procedures. Read more at govinfonow.com/recall/56155-mariner-rdx-pedicle-screws-risk-cross-threading-during-surgery.
Source Summary by GovInfoNow · govinfonow.com/recall/56155-mariner-rdx-pedicle-screws-risk-cross-threading-during-surgery · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1605-2024
Cite this page
“Mariner RDX Pedicle Screws Risk Cross-Threading During Surgery.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56155-mariner-rdx-pedicle-screws-risk-cross-threading-during-surgery. Based on FDA recall #Z-1605-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1605-2024%22&limit=1).
Why it’s dangerous
The screws have a thin lead-in thread that can cause cross-threading between the locking cap and screw head during surgical procedures. This may result in improper implant fixation, potentially causing complications like instability or misalignment in spinal surgery.
Who’s affected
Orthopedic surgeons and medical professionals who use SEASPINE's Mariner RDX pedicle screw systems are most at risk. Patients receiving these implants are not directly affected by the recall.
How to tell if you have this one
Check for reference numbers MX1-000020 to MX1-000070 on the product packaging or implant labels. These models are part of SEASPINE's Mariner RDX Alpha Instruments and Implants series.
- Brand
SEASPINE- Category
Medical device
What to do — step by step
Check Product Details
Review the reference numbers on the product packaging or implant labels to confirm if your screws are affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
FDA distribution: “US Nationwide distribution in the states of MI, GA, VA, IN, FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Georgia, Indiana, Michigan, Virginia.
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-1605-2024 (February 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1605-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.