VADER Pedicle System Torque Wrench — Class II medical device recall Z-0728-2023
Terminated recall by Icotec Ag, reported 2022-12-28, distributed nationwide. During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque l
| Recall number | Z-0728-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Icotec Ag, Altstatten Sg, Switzerland |
| Recall initiated | 2022-11-03 |
| Classified | 2022-12-19 |
| Reported by FDA | 2022-12-28 |
| Terminated | 2026-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 6 devices |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 07640164844589 |
| Serial numbers | 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045 |
| Model numbers | 42-702 |
Product
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Reason for recall
During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm.
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-0728-2023. 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.