BEUDAMED
    FDA Enforcement Class II Terminated

    Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500

    Recall: Z-1234-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1234-2020
    Event ID
    84765
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medicrea International
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 26, 2020
    Initiation Date
    November 11, 2019
    Classification Date
    February 14, 2020
    Termination Date
    October 14, 2020
    Address
    5389 Route De Strasbourg, Vancia, Rillieux La Pape, N/A, France

    Description

    Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500

    Reason

    Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)

    Code Info

    Lot Number:19H0108 Exp.Date: 19/08/2029

    Distribution

    CA, FL

    Quantity

    3 units