BEUDAMED
    FDA Enforcement Class II Ongoing

    Mazor X Surgical System Positioner Type II, REF: ASM0214-02

    Recall: Z-2330-2020 · Reported June 17, 2020

    Enforcement

    Recall Number
    Z-2330-2020
    Event ID
    85387
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2020
    Initiation Date
    December 5, 2019
    Classification Date
    June 9, 2020
    Address
    826 Coal Creek Cir, N/A, Louisville, CO, 80027-9710, United States

    Description

    Mazor X Surgical System Positioner Type II, REF: ASM0214-02

    Reason

    There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in blunt injury [hemorrhage, hematoma, bleeding, or fracture(s)]

    Code Info

    All Lots

    Distribution

    US: ALAR,AZ,CA,CO,CT,FL,GA,IA,ID,IL,IN,KY,MA,MI,MN,MO,NC,ND,NL,NY,OH,PA,SC,TN,TX,UT,VA,WA,WI,WV, OUS: Australia, China, India, Israel, Romania, Singapore, Thailand, United Kingdom, Switzerland, Spain, Germany, Belgium,

    Quantity

    177 Systems