FDA Enforcement
Class II
Ongoing
VADER pedicle system, torque wrench, Catalog Number 42-703
Recall: Z-0701-2024
·
Reported January 17, 2024
Enforcement
- Recall Number
- Z-0701-2024
- Event ID
- 93577
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Icotec Ag
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- January 17, 2024
- Initiation Date
- November 28, 2023
- Classification Date
- January 10, 2024
- Address
- Industriestrasse 12, Altstatten Sg, N/A, Switzerland
Description
VADER pedicle system, torque wrench, Catalog Number 42-703
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.
Code Info
220803-001, 220803-002, 220803-003
Distribution
US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA