Recall Z-0824-2020— Acclarent, Inc.

Name: FDA recall Z-0824-2020
Creator: U.S. Food and Drug Administration
Published: 2019-03-06

Class II · Terminated

Class II FDA medical device recall by Acclarent, Inc., initiated 2019-03-06. It names one FDA 510(k) clearance: K180948. Product: TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877. Reason: The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system..

Recalling firm: Acclarent, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-03-06
Firm location: Irvine, CA, 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, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877

Reason for recall

The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.

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