BEUDAMED
    FDA Recall 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 · Initiated November 6, 2012

    Recall

    Recall Number
    Z-0442-2013
    Event Number
    63711
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KWA
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    November 6, 2012
    Posted
    November 27, 2012
    Terminated
    August 28, 2013
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    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.

    Action

    The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated November 8, 2012 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to take the following actions: Immediately locate and remove the identified device(s) listed below from circulation. Carefully follow the instructions on the enclosed FAX Back Response Form. Fax a copy of the Response Form to 574-372-1683 prior to return of product. Use priority carrier for your shipment. Questions related to notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

    Distribution

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

    Quantity

    4