BEUDAMED
    FDA Recall Terminated

    VariLift Bone Plug w/ End Cap; 14mm Dia, 24mm long; Ref #: CEA1-14-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.

    Recall: Z-0306-2008 · Initiated September 19, 2007

    Recall

    Recall Number
    Z-0306-2008
    Event Number
    45461
    FEI Number
    1000116912
    Product Code
    JDK
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    September 19, 2007
    Posted
    January 9, 2008
    Terminated
    March 10, 2008
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    VariLift Bone Plug w/ End Cap; 14mm Dia, 24mm long; Ref #: CEA1-14-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.

    Reason

    Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)

    Action

    The recalling firm notified consignees of its recall via an Urgent Device Recall letter on 09/19/07. Consignees notified of a labeling error regarding device usage and were told they would be notified by a customer service rep to facilitate return of the recalled devices.

    Distribution

    Nationwide: including direct accounts in CO, KS and TX.

    Quantity

    6 units.