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.
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.
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.
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.
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.
Check for the reference number MX1-001010 on the product. Affected units include specific model lots and serial numbers listed in the recall notice.
Review the reference number on the product to confirm if it matches the listed lots and serial numbers.
The screw heads have partial threads that can cause cross-threading between the locking cap and screw head during surgery, potentially leading to improper implant fixation.
Check for the reference number MX1-001010 on the product. Affected units include specific model lots and serial numbers listed in the recall notice.
The recall record does not specify a remedy.
We’ve drafted a message you can send SEASPINE to request your refund or repair — edit it as you like.
Subject: Recall Z-1620-2024 — SEASPINE SEASPINE Hello, I own a SEASPINE that is covered by recall Z-1620-2024 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.
