BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques. The plate may be temporarily held in place with standard plate holding forceps or the push-pull reduction device.

    Recall: Z-0192-2016 · Reported November 4, 2015

    Enforcement

    Recall Number
    Z-0192-2016
    Event ID
    72360
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 4, 2015
    Initiation Date
    October 7, 2015
    Classification Date
    October 29, 2015
    Termination Date
    August 26, 2016
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques. The plate may be temporarily held in place with standard plate holding forceps or the push-pull reduction device.

    Reason

    The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.

    Code Info

    Threaded Plate Holder-Long for 3.5mm Locking Hole Part Numbers Lot Numbers 324.031 8225613

    Distribution

    Worldwide distribution: US (nationwide) and country of: Canada.

    Quantity

    25