Official recall record
VADER pedicle system, torque wrench, Catalog Number 42-702
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-11-28
- Country of alert
- Switzerland
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Icotec Ag
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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