Product Safety Recalls

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Icotec Ag Recall 91174

Description: VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

Icotec Ag Recall 91174 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0728-2023
Event ID91174
Event DescriptionVADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Product TypeDevices
DistributionUS Nationwide distribution in the state of GA.
Quantity6 devices
Recall ReasonDuring 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 Classification20221228
Device Code InfoUDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045
Center Classification Date20221219
Recall Initiation Date20221103
Recalling FirmIcotec Ag
Initial Notification E-Mail
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