Z-0701-2024 Class II Ongoing
FDA device recall Z-0701-2024 was initiated by Icotec Ag on November 28, 2023 and is designated Class II. 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 limiti… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- January 17, 2024
- Initiation Date
- November 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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.
Distribution Pattern
US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA
Code Information
220803-001, 220803-002, 220803-003