BEUDAMED
    FDA Enforcement Class II Terminated

    Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) revision of previously failed total arthoplasty.

    Recall: Z-0442-2013 · Reported December 5, 2012

    Enforcement

    Recall Number
    Z-0442-2013
    Event ID
    63711
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 5, 2012
    Initiation Date
    November 6, 2012
    Classification Date
    November 27, 2012
    Termination Date
    August 28, 2013
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) revision of previously failed total arthoplasty.

    Reason

    It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.

    Code Info

    Catalog Number: 192411 and Lot Number Identification: 244800

    Distribution

    Nationwide distribution: USA including states of: AZ, MD, and KS.

    Quantity

    4