BEUDAMED
    FDA Enforcement Class II Terminated

    Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position

    Recall: Z-1616-2016 · Reported May 18, 2016

    Enforcement

    Recall Number
    Z-1616-2016
    Event ID
    73657
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Atlas Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 18, 2016
    Initiation Date
    July 26, 2013
    Classification Date
    May 6, 2016
    Termination Date
    July 26, 2019
    Address
    1555 Jupiter Park Dr Ste 4, N/A, Jupiter, FL, 33458-8085, United States

    Description

    Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position

    Reason

    The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.

    Code Info

    Lots #: 8887, 000073, 000135, 00434, and 02518.

    Distribution

    Nationwide Distribution to FL, MO, and WV.

    Quantity

    16