Icotec recalls VADER pedicle system (Catalog 42-703) due to torque wrench malfunction causing loose nut screws. Affected units include specific model numbers sold from 2022.
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 its VADER pedicle system and torque wrench (Catalog Number 42-703) because the torque limiting function may not work correctly, leading to nut screws being too loose during implantation. This could cause improper fixation of the device, potentially affecting surgical outcomes.
The torque wrench used during implantation may not limit tightening properly, causing nut screws to become too loose. This could lead to the device not staying securely in place, potentially affecting the surgical outcome.
Surgical teams using the VADER pedicle system with the specified catalog numbers are affected. Patients undergoing spinal surgery with this device are at risk of improper fixation due to loose screws.
Check for the catalog number 42-703 on the VADER pedicle system and torque wrench. Affected units include model numbers 220803-001, 220803-002, and 220803-003.
Verify the catalog number on the VADER pedicle system and torque wrench. Affected units include model numbers 220803-001, 220803-002, and 220803-003.
Icotec has received notification that one revision of the torque wrench had loose nut screws due to a malfunction in the torque limiting function.
The official recall notice does not specify a remedy or action steps for affected units.
Check for the catalog number 42-703 on the VADER pedicle system and torque wrench. Affected units include model numbers 220803-001, 220803-002, and 220803-003.
We’ve drafted a message you can send Icotec to request your refund or repair — edit it as you like.
Subject: Recall Z-0701-2024 — Icotec Icotec Hello, I own a Icotec that is covered by recall Z-0701-2024 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.
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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.
