VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Reported: December 28, 2022 Initiated: November 3, 2022 #Z-0728-2023
Product Description
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.
Details
- Recalling Firm
- Icotec Ag
- Units Affected
- 6 devices
- Distribution
- US Nationwide distribution in the state of GA.
- Location
- Altstatten Sg
Frequently Asked Questions
What product was recalled? ▼
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702. Recalled by Icotec Ag. Units affected: 6 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2022. Severity: Moderate. Recall number: Z-0728-2023.
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