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
    • 200221-040
    • 200221-041
    • 200221-042
    • 200221-043
    • 200221-044
    • 200221-045
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

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