Recall archive / FDA device enforcement
VADER pedicle system, torque wrench, Catalog Number 42-703 — FDA record Z-0701-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 28, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Classification
- Class II
- Recalling firm
- Icotec Ag
- Quantity
- Not supplied
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0701-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 220803-001, 220803-002, 220803-003 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 17, 2024
- Recall initiation date
- Nov 28, 2023
- Center classification date
- Jan 10, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.