BEUDAMED
    FDA Enforcement Class II Terminated

    MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200

    Recall: Z-0463-2021 · Reported November 25, 2020

    Enforcement

    Recall Number
    Z-0463-2021
    Event ID
    86657
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medicrea International
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 25, 2020
    Initiation Date
    October 8, 2020
    Classification Date
    November 17, 2020
    Termination Date
    May 9, 2024
    Address
    Vancia, Vancia, Rillieux La Pape, N/A, N/A, France

    Description

    MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200

    Reason

    Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-intervention ,

    Code Info

    Lot Numbers: US: 17E0550-1, 17E1089R/2, 18E0278, OUS: 19B0962, 19B0595, 19B0601 Expanded Recall: 11/3/20 17E0550/2, 19B0602, 19B0963 and 19B0964

    Distribution

    CA Foreign:France, Belgium

    Quantity

    17 units US; 8 units OUS Expanded: 1 US and 3 OUS