VADER pedicle system — Class II medical device recall Z-0700-2024
Ongoing recall by Icotec Ag, reported 2024-01-17, distributed in AZ, CA, CO, DE, MI, NC, NY, OH…. icotec has received notification of one revision that had to be carried out because nut screws had become loos
| Recall number | Z-0700-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Icotec Ag, Altstatten Sg, Switzerland |
| Recall initiated | 2023-11-28 |
| Classified | 2024-01-10 |
| Reported by FDA | 2024-01-17 |
| Distributed | AZ, CA, CO, DE, MI, NC, NY, OH, PA, TX |
| Quantity | 79 devices |
| Reason classes | device malfunction |
| Model numbers | 42-702 |
Product
VADER pedicle system, torque wrench, Catalog Number 42-702
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0700-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.