BEUDAMED
    FDA Enforcement Class II Ongoing

    RadiaLux Lighted Retractor (Pink), REF: 50-101-1

    Recall: Z-0953-2023 · Reported January 18, 2023

    Enforcement

    Recall Number
    Z-0953-2023
    Event ID
    91328
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 18, 2023
    Initiation Date
    December 8, 2022
    Classification Date
    January 12, 2023
    Address
    826 Coal Creek Cir, Louisville, CO, 80027-9710, United States

    Description

    RadiaLux Lighted Retractor (Pink), REF: 50-101-1

    Reason

    Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.

    Code Info

    UDI-DI/Lot: 00763000432805/ 705F, 706F, 707F, 708F, 709F

    Distribution

    US Nationwide distribution including in the states of OH, CA, FL, NJ, NY, MN, IN, VA, WA, MS, SC, MO, GA, PA, KS, TN, LA, TX, ME, MA, AL, NC, MD, NH, IL, AZ, MI, NV, MT, OK, SD, RI, CO, CT, NM, NE, DE, WI.

    Quantity

    2317