FDAJuly 9, 2024device
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system.
What to do
FDA enforcement status: Ongoing
Brands named
integra lifesciencesintegra
UPCs
10705031245877
Recall history
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