Class II — Icotec Ag
| Recalling firm | icotec ag |
|---|---|
| Registered facility | ICOTEC AG (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 |
| Quantity | 6 devices |
| Distribution | US Nationwide distribution in the state of GA. |
| Initiated | 2022-11-03 |
| Classified | 2022-12-19 |
| Terminated | 2026-09-10 |
| Recall number | Z-0728-2023 |
| 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-0728-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91174/
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