Icotec recalls VADER pedicle system torque wrenches with catalog numbers 42-702 and specific models due to loose nut screws that may not tighten sufficiently during surgery, posing a risk of improper implantation.
icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.
Icotec is recalling specific models of their VADER pedicle system torque wrenches because the torque limiting function may not work correctly, leading to nut screws being tightened insufficiently during surgery. This could result in improper implantation of spinal hardware.
The torque wrench's limiting function failed during the investigation, meaning nut screws might not have been tightened enough during implantation. This could cause spinal hardware to become loose or misaligned, potentially leading to complications during or after surgery.
Surgical teams using the recalled VADER pedicle system torque wrenches for spinal procedures are most at risk. Patients undergoing spinal surgery with these devices may face complications from improperly tightened hardware.
Check for catalog number 42-702 on the torque wrench. Affected models include specific serial numbers listed in the recall notice, such as 19/01-001 through 230426-043.
Look for the catalog number on the torque wrench to confirm if it's in the list of recalled models.
Reach out to Icotec directly for guidance on next steps if the device is confirmed affected.
Icotec received notification that one revision had to be carried out because nut screws became loose due to the torque wrench's limiting function not working correctly during implantation.
The recall includes specific models with catalog number 42-702 and serial numbers listed in the notice, such as 19/01-001 through 230426-043.
The recall record does not specify a remedy, so users should contact Icotec directly for guidance.
We’ve drafted a message you can send Icotec to request your refund or repair — edit it as you like.
Subject: Recall Z-0700-2024 — Icotec Icotec Hello, I own a Icotec that is covered by recall Z-0700-2024 from Icotec. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
