BEUDAMED
    FDA Enforcement Class II Terminated

    Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085

    Recall: Z-1123-2019 · Reported April 17, 2019

    Enforcement

    Recall Number
    Z-1123-2019
    Event ID
    82379
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 17, 2019
    Initiation Date
    September 21, 2018
    Classification Date
    April 10, 2019
    Termination Date
    September 16, 2020
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085

    Reason

    Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks may include: pain, dissociation, and possible revision surgery

    Code Info

    All lots.

    Distribution

    US: TN, MN, TX, CO, IL, IN, OH, SC, MS, MI, RI, PA, ME, NY, WA, MO, AR, OK, LA, AL, FL, GA, UT, AZ, CA, NV,.

    Quantity

    22