BEUDAMED
    FDA Enforcement Class II Terminated

    Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

    Recall: Z-0875-2015 · Reported December 31, 2014

    Enforcement

    Recall Number
    Z-0875-2015
    Event ID
    69814
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Manufacturing B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 31, 2014
    Initiation Date
    December 4, 2014
    Classification Date
    December 24, 2014
    Termination Date
    June 18, 2015
    Address
    Turpeaux Industrial Park Rd 1 km 123.4, Mercedita, PR, 00715, United States

    Description

    Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

    Reason

    Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Subsequent investigation found the polar-hole threads to be present but non-conforming to specifications, in that the minor diameter was undersized. Investigation also indicates that the issue is isolated and affects only lot 62714305, which

    Code Info

    Item No. 00-6200-054-20; Lot 62714305

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: France, Germany, Iran, Romania, Serbia, Singapore, Taiwan, and United Kingdom.

    Quantity

    68 units