Events

Retiro De Equipo (Recall) de Device Recall TMJ Concepts PatientFitted TMJ Reconstruction Prosthesis System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por TMJ Solutions Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    79614
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1444-2018
  • Fecha de inicio del evento
    2018-03-12
  • Fecha de publicación del evento
    2018-04-19
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162774
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Joint, temporomandibular, implant - Product Code LZD
  • Causa
    This device was mislabeled and is not the correct component for this patient.
  • Acción
    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
  • Modelo / Serial
    Lot: W43963, Serial T170939RM, UDI +B004TYYNNNNRM0/$$3191101W43963/ST170939RMF
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to GA.
  • Descripción del producto
    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
  • Dirección del fabricante
    TMJ Solutions Inc, 2233 Knoll Dr, Ventura CA 93003-7398
  • Empresa matriz del fabricante (2017)
    Tmj Solutions Inc
  • Source
    USFDA