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-1951-2016
  • 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=145299
  • 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
    00588604310 TM CR TIB SZ 3 C-H, 10MM 61746701 61746701 61746702 61752725 61759780 61769546 61776838 61776839 61770816 61785348 61797187 61792632 61792633 61797183 61797182 61797181 61797184 61820708 61820710 61820709 61833813 61839384 61833812 61844335 61844336 00588604312 TM CR TIB SZ 3 C-H, 12MM 61746699 61759781 61776842 61770815 61785349 61797192 61797191 61808975 61833814 61851747 00588604314 TM CR TIB SZ 3 C-H, 14MM 61740710 61785350 61797194 61808984 00588604317 TM CR TIB SZ 3 C-H, 17MM 61746678 61759782 61785351 00588604410 TM CR TIB SZ 4 C-H, 10MM 61733408 61752758 61752759 61759791 61759792 61776830 61770821 61770822 61792647 61792649 61792648 61803945 61803944 61803946 61809003 61809004 61820711 61828074 61828075 61833817 61833818 61839368 61839376 61839390 61857205 61857207 00588604412 TM CR TIB SZ 4 C-H, 12MM 61759793 61776831 61770818 61792651 61803950 61803951 61803952 61809002 61828076 61833821 61833822 61844350 61857204 00588604414 TM CR TIB SZ 4 C-H, 14MM 61733409 61769569 61792653 61803953 61808998 61839386 61857217 00588604417 TM CR TIB SZ 4 C-H, 17MM 61759794 61792654 61803954 00588604510 61746703 61746726 61769547 61770833 61770824 61769548 61780780 61785361 61785362 61780778 61780779 61797201 61792658 61803927 61809014 61809013 61814245 61797202 61814246 61828082 61828083 61828084 61833824 61833825 61839378 61844352 61851749 61857222 61857228 00588604512 TM CR TIB SZ 5 C-H, 12MM 61746719 61769550 61770831 61769551 61785363 61780782 61792659 61797204 61814247 61828085 61833829 61833826 61839380 61851752 00588604514 TM CR TIB SZ 5 C-H, 14MM 61770827 61785364 61797205 61792660 61828081 61844344 61857223 00588604517 TM CR TIB SZ 5 C-H, 17MM 61746709 61770825 61785365  00588604612 TM CR TIB SZ 6 C-H, 12MM 61733401 61746705 61759774 61770838 61780791 61785379 61792665 61809052 61809053 61828087 61851757 00588604614 TM CR TIB SZ 6 C-H, 14MM 61746707 61733402 61759775 61792666 61828088 61851761 00588604617 TM CR TIB SZ 6 C-H, 17MM 61759776 61785378 61809046 00588604710 TM CR TIB SZ 7 C-H, 10MM 61746730 61739891 61746729 61776818 61776819 61770845 61770846 61792672 61797212 61809055 61814252 61828089 61833834 61833832 61851764 61851765 00588604712 TM CR TIB SZ 7 C-H, 12MM 61739889 61746728 61770844 61776821 61797217 61792675 61814251 61828090 61833833 61844354 61851762 00588604714 TM CR TIB SZ 7 C-H, 14MM 61785384 61792676 61809056 00588604717 TM CR TIB SZ 7 C-H, 17MM 61776822 61785385 61809057 00588604810 TM CR TIB SZ 8 C-H, 10MM 61733390 61776826 61792688 61803937 61844355 00588604812 TM CR TIB SZ 8 C-H, 12MM 61769567 61776827 61792689 00588604814 TM CR TIB SZ 8 C-H, 14MM 61733392
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide and Foreign.
  • Descripción del producto
    TM CR TIB SZ 3 C-H, 10MM- 00588604310 || TM CR TIB SZ 3 C-H, 12 mm - 00588604312 || TM CR TIB SZ 3 C-H, 14MM - 00588604314 || TM CR TIB SZ 3 C-H, 17MM - 00588604317 || TM CR TIB SZ 4 C-H 10 MM - 00588604410 || TM CR TIB SZ 4 C-H, 12MM - 00588604412 || TM CR TIB SZ 4 C-H, 14MM - 00588604414 || TM CR TIB SZ 4 C-H, 17MM - 00588604417, 00588604510 || TM CR TIB SZ 5 C-H, 12MM - 00588604512 || TM CR TIB SZ 5 C-H, 14MM - 00588604514 || TM CR TIB SZ 5 C-H, 17MM - 00588604517, 00588604610 || TM CR TIB SZ 6 C-H, 12MM 00588604612 || TM CR TIB SZ 6 C-H, 14 MM 00588604614 || TM CR TIB SZ 6 C-H, 17 MM 00588604617 || TM CR TIB SZ 7 C-H, 10MM - 00588604710 || TM CR TIB SZ 7 C-H, 12MM - 00588604712 || TM CR TIB SZ 7 C-H, 14MM - 00588604714 || TM CR TIB SZ 7 C-H, 17MM - 00588604717 || TM CR TIB SZ 8 C-H, 10MM - 00588604810 || TM CR TIB SZ 8 C-H, 12MM - 00588604812 || TM CR TIB SZ 8 C-H, 14MM - 00588604814
  • 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