FDA Device recall Z-0701-2024
VADER pedicle system, torque wrench, Catalog Number 42-703
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of VADER pedicle system, torque wrench, Catalog Number 42-703 by Icotec Ag, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0701-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-28 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Icotec Ag |
| Distribution | AZ, CA, CO, DE, MI, NC, NY, OH, PA, TX |
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.
Identifiers
| code_info | 220803-001, 220803-002, 220803-003 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0701-2024%22
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