BEUDAMED
    FDA Enforcement Class II Terminated

    IBS - Osteosynthesis screws for bone fixation Model S25 ST014.

    Recall: Z-0397-2016 · Reported December 16, 2015

    Enforcement

    Recall Number
    Z-0397-2016
    Event ID
    72711
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    In2Bones, SAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 16, 2015
    Initiation Date
    November 18, 2015
    Classification Date
    December 9, 2015
    Termination Date
    August 19, 2016
    Address
    28 Chemin Du Petit Bois, N/A, Ecully, N/A, N/A, France

    Description

    IBS - Osteosynthesis screws for bone fixation Model S25 ST014.

    Reason

    One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.

    Code Info

    1509058

    Distribution

    US Distribution to the state of :TN

    Quantity

    20 units