BEUDAMED
    FDA Enforcement Class II Terminated

    DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.

    Recall: Z-0708-2013 · Reported January 30, 2013

    Enforcement

    Recall Number
    Z-0708-2013
    Event ID
    63665
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 30, 2013
    Initiation Date
    November 7, 2012
    Classification Date
    January 23, 2013
    Termination Date
    December 24, 2013
    Address
    325 Paramount Dr, N/A, Raynham, MA, 02767-5199, United States

    Description

    DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.

    Reason

    Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

    Code Info

    All lots

    Distribution

    Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.

    Quantity

    24 units