Icotec Ag is recalling 79 VADER pedicle system torque wrenches because the tool's torque-limiting function can malfunction during spinal surgery. When this happens, the nut screws used in the implant may not be tightened enough, leading them to become loose over time. Icotec has received one report of a patient requiring a follow-up revision surgery because the screws became loose following an initial implantation.
If the torque wrench does not tighten the nut screws to the correct specification, the spinal implant can become unstable. This instability can cause the screws to loosen, potentially leading to pain, loss of surgical correction, or the need for an additional invasive surgery to fix the device.
Manufacturer initiated contact via e-mail.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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