Events

Retiro De Equipo (Recall) de 45mm Left Standard Offset Mandible

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 Biomet Microfixation, 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
    60910
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0823-2012
  • Fecha de inicio del evento
    2010-04-07
  • Fecha de publicación del evento
    2012-01-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106771
  • 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
    Mandibular condyle prosthesis - Product Code MPL
  • Causa
    Biomet microfixation, inc., jacksonville, fl recalled part # 24-6546, 45mm left standard mandible and part # 24-6646, 45mm left standard offset mandible due to a lot of 24-6246 being etched & labeled as 24-6646 and the reverse, a lot of 24-6646 being etched and labeled as 24-6546.
  • Acción
    Biomet Microfixation Inc sent an URGENT-Medical Device Recall notice to all consignees. The letter informs the customers to discontinue use of the items and return them to Biomet Microfixation.They also ask all customers to complete the inventory reconciliation sheet and return it by fax to the Global Complaint Coordinator. The letter also states that if the product was further distributed, the letter must be forwarded on to the firm's customers. For questions call 1-800-874-7711 or 904-741-4400, ext 468.

Device

45mm Left Standard Offset Mandible
  • Modelo / Serial
    Product Part # 24-6646, lot # 080300
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) in the state of Florida and in the countries Germany and Guatemala.
  • Descripción del producto
    The 45mm Left Standard Offset Mandible is one component in the Total Temporomandibular Joint (TMJ) Replacement System used to functionally reconstruct a diseased and/or damaged temporomandibular joint. || The component is labeled in part: "REF: 24-6646***TMJ SYSTEM LEFT STANDARD OFFSET MANDIBULAR COMPONENT***QTY 00001***45MM / 7 HOLE CO-CR-MO, TI-6AL-4V ALLOY***BIOMET MICROFIXATION 1520 Tradeport Drive Jacksonville, FL 32218 USA www.biometmicrofixation.com*** || Product Recall: 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 glenoid fossa components. Both components are available in multiple sizes as right and left side specific designs and are attached to bone by screws. Mandibular (Condylar) Prosthesis- The prosthesis is designed to replace the articular surface of the mandibular condyle. The mandibular prosthesis is offered in 3 different sizes: 45mm, 50mm, and 55mm, designated left and right. The mandibular prosthesis is offered in 3 styles:Standard, Offset, and Narrow, to fit a diverse range of mandibular sizes and shapes. The mandibular prosthesis is made of Cobalt Chromium Alloy. The under-surface of the prosthesis is coated with titanium plasma spray for increased bony integration to the mandibular prosthesis.
  • Manufacturer
    Biomet Microfixation, Inc.

Manufacturer

Biomet Microfixation, Inc.
  • Dirección del fabricante
    Biomet Microfixation, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA