BEUDAMED
    FDA Enforcement Class II Ongoing

    Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140

    Recall: Z-0828-2020 · Reported January 29, 2020

    Enforcement

    Recall Number
    Z-0828-2020
    Event ID
    84595
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medicrea International
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 29, 2020
    Initiation Date
    September 16, 2019
    Classification Date
    January 18, 2020
    Address
    5389 Route De Strasbourg, Vancia, Rillieux La Pape, N/A, France

    Description

    Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140

    Reason

    Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded

    Code Info

    Lot number(s) : 18G0368; 19H0009; 18F0138; 18G0038

    Distribution

    Nationwide

    Quantity

    190 units