FDAFDA · Food and drugs·Recall number Z-0728-2023
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Published December 28, 2022 · Recall initiated: November 3, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Icotec Ag
- Distributor
- US Nationwide distribution in the state of GA.
- Lot
- UDI/DI: (01) 07640164844589, Serial Numbers: 200221-040, 200221-041, 200221-042, 200221-043, 200221-044, 200221-045
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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