BEUDAMED
    FDA Enforcement Class II Terminated

    Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjustment to fusion in the treatment of degenerative disc disease (DDD), sponylolisthesis, spinal stenosis, tumors, trauma (i.e. fracture).

    Recall: Z-0239-2018 · Reported December 20, 2017

    Enforcement

    Recall Number
    Z-0239-2018
    Event ID
    78592
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Amendia, Inc dba Spinal Elements
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 20, 2017
    Initiation Date
    November 13, 2017
    Classification Date
    December 13, 2017
    Termination Date
    October 15, 2019
    Address
    1755 W Oak Pkwy, N/A, Marietta, GA, 30062-2260, United States

    Description

    Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjustment to fusion in the treatment of degenerative disc disease (DDD), sponylolisthesis, spinal stenosis, tumors, trauma (i.e. fracture).

    Reason

    Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.

    Code Info

    Part No. CSF-40-12, Lot No. 132635

    Distribution

    US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.

    Quantity

    82 units