BEUDAMED
    FDA Recall Terminated

    MIKA Speedblock, Size 8-12. The MIKA Speedblock is placed on the distal femur as a guide for making the anterior, posterior and both chamfer cuts.

    Recall: Z-2164-2010 · Initiated April 26, 2010

    Recall

    Recall Number
    Z-2164-2010
    Event Number
    55605
    FEI Number
    1000116912
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 26, 2010
    Posted
    August 2, 2010
    Terminated
    December 15, 2011
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    MIKA Speedblock, Size 8-12. The MIKA Speedblock is placed on the distal femur as a guide for making the anterior, posterior and both chamfer cuts.

    Reason

    A crack or complete fracture at the anterior chamfer cut slot may occur on the size 8, 10, and 12 MIKA Speedblocks.

    Action

    An "Urgent Field Safety Notice" Letter dated May 20, 2010, was sent to the customers. The letter described the product, problem and action to be taken by customer. The customers were instructed to locate, inspect and verify the quantity still in their possession, complete and return the field safety notice response page to Beth Onderlinde at [email protected] or fax to 512-834-6313 by June 7, 2010, (completion of form is mandatory), and identify and inform customers that they may have distributed/sold product to, of the notice. The customer was also instructed to please inspect the listed part numbers prior to use and again after use, if a crack is found in the speedblock, contact your Customer Service Representative and be sure to utilize the femoral/tibial impactor (801-01-043) for impaction of the speedblock and reiterate to your physicians that the MIKA mini slaphammer (800-02-290) should be used for speedblock removal. The product will be replaced as it becomes available. If you have any questions, call Director of Commercial Logistics at (512) 834-6330 or International Customer Service at (512) 834-6275. You may also contact our EU Authorized Representative, MDSS GmbH, via email at [email protected] or via phone at +49 (0) 511 6262 8630.

    Distribution

    Worldwide distribution.

    Quantity

    729 and 67 specials