Retiro De Equipo (Recall) de Device Recall Hinged Knee Support

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Stocking, medical support (to prevent pooling of blood in legs - Product Code DWL
  • Causa
    During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
  • Acción
    Zimmer sent an Urgent: Device Removal Letters dated April 8, 2014 to their customers. The letter identified the affected product, probllem and actions to be taken. Customers were instructed to review this notification, iIdentify and quarantine the affected product to prevent further distribution or use, complete the attached Response Form and return it via email. Return affected product to: Zimmer Surgical Attn: QA/RA Dept.- Recall 200 West Ohio Avenue Dover, Ohio 44622 USA Please include a copy of the Response Form with the shipment. For returns outside the US, please email obtain an IRA (international return authorization) number. The IRA request should include the part number(s) being returned and the quantity. Please write the associated IRA number on the outside of the box. 4. Zimmer will credit your account for returned Drop-Lok" Knee Braces, Cartilage Knee Braces, Hinged Knee Supports, or Neoprene Tennis Elbow Supports. Please return a copy of the completed response form along with your returned product to ensure proper credit. Important: Please distribute this notification to all personnel within your organization who need to be aware. If you have further transferred affected product(s), please provide the customer's information on the Business Response Form to Zimmer. For questions call 330-354-0989


  • Modelo / Serial
    Model #: 00-1773-002-00 through 00-1773-008-00
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: AK, AZ, CA, FL, GA, IA, IL, IN, LA, MD, MI, MO NC, NE, NV, NY, OH, OK, OR, PA, RI, SD, TX, UT, VA, VT, WA, WI & WV and countries of: AUSTRALIA, CANADA, GERMANY, IRAQ, ITALY, SAUDI ARABIA, TUNISIA & UNITES ARAB EMIRATES.
  • Descripción del producto
    Hinged Knee Support***LATEX FREE" || Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation.
  • Manufacturer


  • Dirección del fabricante
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Empresa matriz del fabricante (2017)
  • 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