BEUDAMED
    FDA Recall Terminated

    Keramos Replacement Polyethylene Liner, 64mm; Cat. #496-28-064; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758.

    Recall: Z-1789-2008 · Initiated April 11, 2008

    Recall

    Recall Number
    Z-1789-2008
    Event Number
    47870
    FEI Number
    1000116912
    Product Code
    MRA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 11, 2008
    Posted
    September 5, 2008
    Terminated
    January 21, 2009
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    Keramos Replacement Polyethylene Liner, 64mm; Cat. #496-28-064; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758.

    Reason

    Keramos Replacement Polyethylene Liner used as a replacement for the Keramos ceramic liner in revision hip replacement surgeries marketed without 510(k) approval.

    Action

    An Urgent: Medical Device Recall letter was issued by the firm on 04/11/08. Consignees were told that they did not have marketing approval for the Polyethylene Backup Liner (poly liner) for use with the Keramos Ceramic-on-Ceramic Acetabular System. Therefore, they are removing it from the market while pursuing marketing approval.

    Distribution

    Class II Recall - Nationwide --- including the following states: AZ, CA, FL, MA, MO, NV, SC, SD and TX.

    Quantity

    28 units.