BEUDAMED
    FDA Enforcement Class II Terminated

    Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibular joint. It is indicated for patients with one or more of the following conditions: Inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; Failed tissue graft; Failed alloplastic joint reconstruction; Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion

    Recall: Z-1444-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1444-2018
    Event ID
    79614
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TMJ Solutions Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 25, 2018
    Initiation Date
    March 12, 2018
    Classification Date
    April 19, 2018
    Termination Date
    July 23, 2019
    Address
    2233 Knoll Dr, Ventura, CA, 93003-7398, United States

    Description

    Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibular joint. It is indicated for patients with one or more of the following conditions: Inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; Failed tissue graft; Failed alloplastic joint reconstruction; Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion

    Reason

    This device was mislabeled and is not the correct component for this patient.

    Code Info

    Lot: W43963, Serial T170939RM, UDI +B004TYYNNNNRM0/$$3191101W43963/ST170939RMF

    Distribution

    US Distribution to GA.

    Quantity

    1