BEUDAMED
    FDA Recall Terminated

    Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.

    Recall: Z-0386-2013 · Initiated August 27, 2012

    Recall

    Recall Number
    Z-0386-2013
    Event Number
    63126
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    KWZ
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    August 27, 2012
    Posted
    November 20, 2012
    Terminated
    August 27, 2013
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.

    Reason

    Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton.

    Action

    Zimmer contacted their customer beginning the week of August 27, 2012, via telephone. Zimmer informed the customer the reason of the recall. The customer was instructed to quarantine and return the device to Zimmer Product Service, 1777 W. Center St. Warsaw, IN 46580. The customer was asked to provide information if the product was further distributed. For further questions please call 574-372-4316.

    Distribution

    USA (nationwide) including the states of Ohio, Carolinas and New England.

    Quantity

    1