Recall Z-2507-2024— Integra LifeSciences Corp.

Name: FDA recall Z-2507-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-09

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2024-07-09. It names one FDA 510(k) clearance: K180948. Product: 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. Reason: 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..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Ongoing
Initiated: 2024-07-09
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K180948 — TruDi NAV Suction InstrumentsAcclarent, Inc.·cleared 2018-07-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.