BEUDAMED
    FDA Enforcement Class II Terminated

    FPS 35mm x 3.5 mm non-locking screw

    Recall: Z-2835-2016 · Reported September 28, 2016

    Enforcement

    Recall Number
    Z-2835-2016
    Event ID
    74849
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho Solutions Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 28, 2016
    Initiation Date
    July 21, 2016
    Classification Date
    September 16, 2016
    Termination Date
    October 12, 2016
    Address
    330 Franklin Tpke, Mahwah, NJ, 07430-3524, United States

    Description

    FPS 35mm x 3.5 mm non-locking screw

    Reason

    Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.

    Code Info

    Part number - OS326835 Lot number: 10100/269A12-68051

    Distribution

    US Distribution

    Quantity

    15