Reported Dec 28, 2022 · Ongoing
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Icotec Ag
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Icotec Ag · Industriestrasse 12 · Altstatten Sg · N/A
Is this the product you have?
- VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
- Lot codes and dates
- UDI/DI(01) 07640164844589
- Serial Numbers
200221-040200221-041200221-042200221-043200221-044200221-045
- Amount recalled
- 6 devices
Where it was sold
- Nationwide
- GA
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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