Events

Retiro De Equipo (Recall) de Device Recall NaturalKnee II 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 Zimmer, 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
    67503
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1255-2014
  • Fecha de inicio del evento
    2014-02-25
  • Fecha de publicación del evento
    2014-03-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125632
  • 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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    A complaint was received for a discolored all poly tibia. root cause analysis found that the discoloration was the result of free radical oxidation. the oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.
  • Acción
    Beginning 2/25/2014 all distributors were notified via electronic mail. Hospital risk managers and distributors, surgeons with affected inventory will also be notified via courier or direct mail. The Urgent Lot Specific Recall Notice identified the issue and responsibilities. Distributors were asked to locate and remove the affected product in their territory, as well as identifying hospitals and surgeons who have previously implanted the affected product. Distributors were asked to return on-hand affected products to Zimmer and ensure all of their products are accounted for using the form provided in the letter and email it back to corporatequality.postmarket@zimmer.com. Hospital risk managers and surgeons were asked to locate affected product and return it to their Zimmer sales representative. Questions or concerns should be addressed to customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST Communications outside of the United States will occur approximately two weeks after the United States communications. 100 % effective checks will be done.

Device

Device Recall NaturalKnee II System
  • Modelo / Serial
    Item Number 625001609 625001613 625001619 625001709 625001711 625001713 625001719 625002613 625002616 625002719 625002722 630809510 630811410 630811510 630813410 630813510 630816210 630816410 630816510 630819010 630819110 630819210 630819310 630819410 630819510 635000009 635001009 635001011 635001111 635001116 635002009 635002011 635002109 635002111 635002113 635003009 635003011 635003013 635003016 635003109 635003113 635003116 635004009 635004011 635004016 635004111 635004113 635004119 635005013 635005019 635005111 635005116 635006109 670501916 670501919 670503819 670503911 670503916
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.
  • Descripción del producto
    Natural-Knee¿ II System || ULTRA CONG INS LT SZA/9MM || ULTRA CONG INS LT SZA/13M || ULTRA CONG INS LT SZA/19M || ULTRA CONG INS RT SZA/9MM || ULTRA CONG INS RT SZA/11M || ULTRA CONG INS RT SZA/13M || ULTRA CONG INS RT SZA/19M || ULTRA CONG INS LT SZB/13M || ULTRA CONG INS LT SZB/16M || ULTRA CONG INS RT SZB/19M || ULTRA CONG INS RT SZB/22M || NKII ROT PLTFM U/C INS, 9 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || ALL POLY CONG TIB LT SZ00 || ALL POLY CONG TIB LT SZ0/ || ALL POLY CONG TIB LT SZ0/ || ALL POLY CONG TIB RT SZ0/ || ALL POLY CONG TIB RT SZ0/ || ALL POLY CONG TIB LT SZ1/ || ALL POLY CONG TIB LT SZ1/ || ALL POLY CONG TIB RT SZ1/ || ALL POLY CONG TIB RT SZ1/ || ALL POLY CONG TIB RT SZ1/ || ALL POLY CONG TIB LT SZ2/ || ALL POLY CONG TIB LT SZ2/ || ALL POLY CONG TIB LT SZ2/ || ALL POLY CONG TIB LT SZ2/ || ALL POLY CONG TIB RT SZ2/ || ALL POLY CONG TIB RT SZ2/ || ALL POLY CONG TIB RT SZ2/ || ALL POLY CONG TIB LT SZ3/ || ALL POLY CONG TIB LT SZ3/ || ALL POLY CONG TIB LT SZ3/ || ALL POLY CONG TIB RT SZ3/ || ALL POLY CONG TIB RT SZ3/ || ALL POLY CONG TIB RT SZ3/ || ALL POLY CONG TIB LT SZ4/ || ALL POLY CONG TIB LT SZ4/ || ALL POLY CONG TIB RT SZ4/ || ALL POLY CONG TIB RT SZ4/ || ALL POLY CONG TIB RT SZ5/ || PS TIB INS RT SZ1/2 16MM || PS TIB INS RT SZ1/2 19MM || PS TIB INS LT SZ00/0 19MM || PS TIB INS RT SZ00/0 11MM || PS TIB INS RT SZ00/0 16MM
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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