BEUDAMED
    FDA Recall Terminated

    Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free, Biomet Orthopedics, Inc., Warsaw, IN; Product Number: 418000. Vacuum mixing and vacuum collection system and application system for bone cement.

    Recall: Z-1480-2009 · Initiated April 9, 2009

    Recall

    Recall Number
    Z-1480-2009
    Event Number
    52009
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JDZ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 9, 2009
    Posted
    June 30, 2009
    Terminated
    October 6, 2010
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free, Biomet Orthopedics, Inc., Warsaw, IN; Product Number: 418000. Vacuum mixing and vacuum collection system and application system for bone cement.

    Reason

    The package may contain two short mixing rods instead of one long and one short rod.

    Action

    Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated April 9, 2009 instructing distributors to visit each hospital consignee, deliver a copy of the recall notification and replacement product and to pick up, and return the affected product. Further questions may be addressed to the Biomet Orthopedics at 1-800-348-9500.

    Distribution

    Nationwide Distribution - Including AL, AR, FL, IL, LA, MN, NE, NC, NV, OH, OK, SC, SD, WA and WI.

    Quantity

    250