BEUDAMED
    FDA Enforcement Class II Ongoing

    Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044

    Recall: Z-0458-2023 · Reported December 14, 2022

    Enforcement

    Recall Number
    Z-0458-2023
    Event ID
    91063
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Intersect ENT, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 14, 2022
    Initiation Date
    October 21, 2022
    Classification Date
    December 8, 2022
    Address
    1555 Adams Dr, N/A, Menlo Park, CA, 94025-1439, United States

    Description

    Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044

    Reason

    Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.

    Code Info

    REF: 60044, UDI-DI: M927600440, Lot: 22041901

    Distribution

    US Nationwide distribution including in the states of NC, IL, KS, OR, WI, TX, FL, MN, WY, UT, NY, CA, NJ, OK, MD, HI, MT, TN, MO, IA, MA, AZ, GA, LA, ID, SC, WA, SD, ND, CO, NV.

    Quantity

    611 units