BEUDAMED
    FDA Recall Terminated

    Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in hip replacement surgeries.

    Recall: Z-1063-05 · Initiated June 8, 2005

    Recall

    Recall Number
    Z-1063-05
    Event Number
    32301
    FEI Number
    1000116912
    Product Code
    MRA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 8, 2005
    Posted
    August 3, 2005
    Terminated
    April 19, 2007
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in hip replacement surgeries.

    Reason

    Labeling on the Keramos Ceramic Femoral Heads and Liner indicates the product expiration date of 6 years instead of 5 years.

    Action

    The firm notified all sales agencies and affected products are on return.

    Distribution

    Nationwide

    Quantity

    Nationwide including: TX, MS, FL, SC, GA, CA, PA, MA, NJ, MD, OK, MO, AZ, SD, UT, ID