Events

Recall of Device Recall TMJ Concepts PatientFitted TMJ Reconstruction Prosthesis System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by TMJ Solutions Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79614
  • Event Risk Class
    Class 2
  • Event Number
    Z-1444-2018
  • Event Initiated Date
    2018-03-12
  • Event Date Posted
    2018-04-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162774
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Joint, temporomandibular, implant - Product Code LZD
  • 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.

Device

Device Recall TMJ Concepts PatientFitted TMJ Reconstruction Prosthesis System
  • Model / Serial
    Lot: W43963, Serial T170939RM, UDI +B004TYYNNNNRM0/$$3191101W43963/ST170939RMF
  • Product Classification
    Dental Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Distribution to GA.
  • Product 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
  • Manufacturer
    TMJ Solutions Inc

Manufacturer

TMJ Solutions Inc
  • Manufacturer Address
    TMJ Solutions Inc, 2233 Knoll Dr, Ventura CA 93003-7398
  • Manufacturer Parent Company (2017)
    Tmj Solutions Inc
  • Source
    USFDA