Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VADER pedicle system Recalled by Icotec Ag Due to icotec has received notification of one revision that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Icotec Ag directly.
Affected Products
VADER pedicle system, torque wrench, Catalog Number 42-702
Quantity: 79 devices (US only)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 10 states: AZ, CA, CO, DE, MI, NY, NC, OH, PA, TX
About Icotec Ag
Icotec Ag has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report