Class II — Icotec Ag
| Recalling firm | icotec ag |
|---|---|
| Registered facility | ICOTEC AG (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | VADER pedicle system, torque wrench, Catalog Number 42-703 |
| Distribution | US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA |
| Initiated | 2023-11-28 |
| Classified | 2024-01-10 |
| Recall number | Z-0701-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Icotec Ag (Z-0701-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93577/
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