BEUDAMED
    FDA Recall Terminated

    DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.

    Recall: Z-0713-2013 · Initiated November 7, 2012

    Recall

    Recall Number
    Z-0713-2013
    Event Number
    63665
    Firm
    DePuy Spine, Inc.
    FEI Number
    1526439
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    November 7, 2012
    Posted
    January 24, 2013
    Terminated
    December 24, 2013
    Address
    325 Paramount Dr, Raynham, MA, 02767-5199

    Description

    DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 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.

    Action

    DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to [email protected]. For questions call Linda Regan @508-977-6606.

    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

    10 units