Recall Z-0700-2024— Icotec Ag
Class II · Ongoing
Class II FDA medical device recall by Icotec Ag, initiated 2023-11-28. It names one FDA 510(k) clearance: K222789. Product: VADER pedicle system, torque wrench, Catalog Number 42-702. Reason: 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..
- Recalling firm
- Icotec Ag
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-28
- Firm location
- Altstatten Sg, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
VADER pedicle system, torque wrench, Catalog Number 42-702
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.