Events

Retiro De Equipo (Recall) de Zimmer

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 Zimmer Trabecular Metal Technology, 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
    73536
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1953-2016
  • Fecha de inicio del evento
    2016-04-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-11-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145915
  • 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
    Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • Causa
    Zimmer biomet is initiating a recall of specific lots of foil pouched, sterile trabecular metal implants that were manufactured between april 2011 and october 2012. the foil pouches are part of a dual barrier system to provide sterile integrity.
  • Acción
    Zimmer issued an Urgent Medical Device Recall Letter dated 4/15/2016.

Device

Zimmer
  • Modelo / Serial
    00588606510 TM MONO TIB STR GRN SZ 5 10MM 61769554 61780786 61803934 00588606512 TM MONO TIB STR GRN SZ 5 12MM 61769555 61785358 00588606514 TM MONO TIB STR GRN SZ 5 14MM 61746710 61769556 61785359 61803935 00588606517 TM MONO TIB STR GRN SZ 5 17MM 61739874 61780787 61785360 61792655 61803936 61809005 00588606610 TM MONO TIB STR GRN SZ 6 10MM 61770839 61780793 61785374 61809020 61820718 61839382 00588606612 TM MONO TIB STR GRN SZ 6 12MM 61739882 61733397 61759778 61770840 61785375 61809018 61844376 00588606614 TM MONO TIB STR GRN SZ 6 14MM 61739885 61759779 61780795 61785376 61809015 00588606617 TM MONO TIB STR GRN SZ 6 17MM 61739883 61785377 61820719 00588606710 TM MONO TIB STR BLUE SZ 7 10MM 61769582 61792678 61797213 61851763 00588606712 TM MONO TIB STR BLUE SZ 7 12MM 61785386 61792681 61797214 61857235 00588606714 TM MONO TIB STR BLUE SZ 7 14MM 61780797 61785387 61809058 00588606717 TM MONO TIB STR BLUE SZ 7 17MM 61785388 61814249 00588607510 TM MONO TIB STR GRN SZ 5 10MM 61785366 61803928 61820713 61844346 00588607512 TM MONO TIB STR GRN SZ 5 12MM 61770823 61792661 61803929 61851753 00588607514 TM MONO TIB STR GRN SZ 5 14MM 61739865 61785369 61803931 00588607517 TM MONO TIB STR GRN SZ 5 17MM 61785370
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide and Foreign.
  • Descripción del producto
    TM MONO TIB STR GRN SZ 5 - 00588606510 || TM MONO TIB STR GRN SZ 5 12MM - 00588606512 || TM MONO TIB STR GRN SZ 5 14MM - 00588606514 || TM MONO TIB STR GRN SZ 5 17MM - 00588606517 || TM MONO TIB STR GRN SZ 6 10MM - 00588606610 || TM MONO TIB STR GRN SZ 6 12MM - 00588606612 || TM MONO TIB STR GRN SZ 6 14MM - 00588606614 || TM MONO TIB STR GRN SZ 6 17MM - 00588606617 || TM MONO TIB STR BLUE SZ 7 10MM - 00588606710 || TM MONO TIB STR BLUE SZ 7 12MM - 00588606712 || TM MONO TIB STR BLUE SZ 7 14MM - 00588606714 || TM MONO TIB STR BLUE SZ 7 17MM - 00588606717 || TM MONO TIB STR GRN SZ 5 10MM - 00588607510 || TM MONO TIB STR GRN SZ 5 12MM - 00588607512 || TM MONO TIB STR GRN SZ 5 14MM - 00588607514 || TM MONO TIB STR GRN SZ 5 17MM - 00588607517
  • Manufacturer
    Zimmer Trabecular Metal Technology, Inc.

Manufacturer

Zimmer Trabecular Metal Technology, Inc.
  • Dirección del fabricante
    Zimmer Trabecular Metal Technology, Inc., 10 Pomeroy Rd, Parsippany NJ 07054-3722
  • 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