Icotec Ag Recall 91174
Description: VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Icotec Ag Recall 91174 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0728-2023 |
| Event ID | 91174 |
| Event Description | VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of GA. |
| Quantity | 6 devices |
| Recall 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. |
| Device Classification | 20221228 |
| Device Code Info | UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045 |
| Center Classification Date | 20221219 |
| Recall Initiation Date | 20221103 |
| Recalling Firm | Icotec Ag |
| Initial Notification | |
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