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.
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.
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.
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.
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.
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.
Review the reference numbers on the product packaging or implant labels to confirm if your screws are affected.
No, patients receiving these implants are not directly affected by the recall. The risk is for medical professionals using the screws during surgery.
If you are a medical professional using these screws, check the reference numbers on the packaging or labels to determine if your product is affected. The recall does not provide specific action steps for affected products.
Look 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.
We’ve drafted a message you can send SEASPINE to request your refund or repair — edit it as you like.
Subject: Recall Z-1605-2024 — SEASPINE SEASPINE Hello, I own a SEASPINE that is covered by recall Z-1605-2024 from SEASPINE. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
