BEUDAMED
    FDA Enforcement Class II Terminated

    DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.

    Recall: Z-1318-2015 · Reported April 1, 2015

    Enforcement

    Recall Number
    Z-1318-2015
    Event ID
    70736
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    In2Bones, SAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 1, 2015
    Initiation Date
    March 9, 2015
    Classification Date
    March 25, 2015
    Termination Date
    May 19, 2016
    Address
    28 Chemin Du Petit Bois, Ecully, N/A, France

    Description

    DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.

    Reason

    Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.

    Code Info

    Batch numbers: 1404032, 1412011

    Distribution

    Distributed in the state of TN.

    Quantity

    35 units