BEUDAMED
    FDA Recall Terminated

    Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.

    Recall: Z-0769-2013 · Initiated September 14, 2012

    Recall

    Recall Number
    Z-0769-2013
    Event Number
    63531
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 14, 2012
    Posted
    February 4, 2013
    Terminated
    June 20, 2014
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.

    Reason

    Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.

    Action

    Zimmer sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated September 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.The firm expanded the scope of the recall in January 2013 to include devices that use a secondary mean of fixation. New recall letters will be submitted to distributors and surgeons.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.

    Quantity

    275,952 units