VADER pedicle system, torque wrench, Catalog Number 42-703
Reported: January 17, 2024 Initiated: November 28, 2023 #Z-0701-2024
Product Description
VADER pedicle system, torque wrench, Catalog Number 42-703
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.
Details
- Recalling Firm
- Icotec Ag
- Distribution
- US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA
- Location
- Altstatten Sg
Frequently Asked Questions
What product was recalled? ▼
VADER pedicle system, torque wrench, Catalog Number 42-703. Recalled by Icotec Ag.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 17, 2024. Severity: Moderate. Recall number: Z-0701-2024.
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