BEUDAMED
    FDA Recall Terminated

    Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm, Lengths 30mm-55mm, labeled non-sterile. The Capless LI Pedicle Screw System is indicated for the treatment of sever spondylolisthesis of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft.

    Recall: Z-1694-2009 · Initiated March 24, 2009

    Recall

    Recall Number
    Z-1694-2009
    Event Number
    51956
    Firm
    X Spine Systems Inc
    FEI Number
    3005031160
    Product Code
    MNH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 24, 2009
    Posted
    August 19, 2009
    Terminated
    April 25, 2012
    Address
    452 Alexandersville Rd, Miamisburg, OH, 45342-3658

    Description

    Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm, Lengths 30mm-55mm, labeled non-sterile. The Capless LI Pedicle Screw System is indicated for the treatment of sever spondylolisthesis of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft.

    Reason

    A defect cause was discovered following a customer complaint pertaining to a post operative dissociation of the Capless Li Screw construct. The screw assembly is made up of three parts; a cup which locks onto a 5.5mm rod, a yoke that cradles the rod during fusion, and a screw that attached to the vertebra. The screw ball on the screw was manufactured out of tolerance (undersized).

    Action

    X Spine Systems Inc. issued advisory notices in March 2009 to Consignees notifying them of the problem and requesting all affected product be returned to the firm. The firm also conducted telephone calls and emails for the return of the product. For further information, contact X Spine Systems Inc. at 1-937-847-8400 extension 115.

    Distribution

    Worldwide Distribution -- Including states of AZ, CA, CO, FL, ID, IN, MO, MS, NV, OK, TN, TX, UT and WY and countries of Spain, South Africa and the United Kingdom.

    Quantity

    9,613 units