BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replacement system is a two-component system comprised of mandibular condyle and a glenoid fossa components. Both components are available in multiple stock sizes as right and left specific designs and are attached to the bones by screws.

    Recall: Z-2566-2014 · Reported September 10, 2014

    Enforcement

    Recall Number
    Z-2566-2014
    Event ID
    67547
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet Microfixation, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 10, 2014
    Initiation Date
    September 20, 2013
    Classification Date
    September 2, 2014
    Termination Date
    October 3, 2014
    Address
    1520 Tradeport Dr, Jacksonville, FL, 32218-2480, United States

    Description

    Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replacement system is a two-component system comprised of mandibular condyle and a glenoid fossa components. Both components are available in multiple stock sizes as right and left specific designs and are attached to the bones by screws.

    Reason

    Product mix occurred prior to final package and labeling process.

    Code Info

    Part #CP751506 Lot #478490

    Distribution

    Worldwide Distribution to Denmark only.

    Quantity

    1