Device product
TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
Z-0825-2020
Product summary
- Firm
- Acclarent, Inc.
- Event
- Event 84398
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0825-2020
Official wording
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.
Code information: Lot # 1901080, 1901177, 1901219 The TruDi NAV Suction Instruments have a shelf life of 30 reprocessing cycles.
Distribution pattern: US: WI, IL, NE, CA, OH, NY OUS: None
Derived failure modes
-
Unknown
The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.