BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0458-2023 · Initiated October 21, 2022

    Recall

    Recall Number
    Z-0458-2023
    Event Number
    91063
    Firm
    Intersect ENT, Inc.
    FEI Number
    3008301917
    Product Code
    OWO
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    October 21, 2022
    Posted
    December 8, 2022
    Address
    1555 Adams Dr, Menlo Park, CA, 94025-1439

    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.

    Action

    On 10/21/22, recall notices from Medtronic/Intersect ENT were sent to customers who were asked to do the following: 1) Identify, quarantine, and return all unused affected products to Medtronic. 2) Complete and return the customer confirmation form. 3) Distribute the recall notice to all others in your organization who should be aware, or to any organization where the potentially affected devices have been transferred. The following contact information was provided: [email protected] and [email protected]

    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