BEUDAMED
    FDA Recall 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 · Initiated March 12, 2018

    Recall

    Recall Number
    Z-1444-2018
    Event Number
    79614
    Firm
    TMJ Solutions Inc
    FEI Number
    3001237463
    Product Code
    LZD
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    March 12, 2018
    Posted
    April 19, 2018
    Terminated
    July 23, 2019
    Address
    2233 Knoll Dr, Ventura, CA, 93003-7398

    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.

    Action

    TMJ Concepts sent an Medical Device Recall Communication letter dated March 12, 2018. INSTRUCTIONS: The implants for this case should not be used and should be immediately quarantined. We request that you return the entire case (the anatomical bone model together with both the fossa and mandibular components) to us by FedEx Priority Overnight Delivery. Any bone screws and drills that were provided with the shipment can be retained at your hospital and do not need to be returned. For further questions, please call (805) 650-3391.

    Distribution

    US Distribution to GA.

    Quantity

    1