Events

Retiro De Equipo (Recall) de Device Recall Zimmer Anatomical Shoulder Handle for Rasp

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 Gmbh.

¿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
    70993
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1523-2015
  • Fecha de inicio del evento
    2015-03-18
  • Fecha de publicación del evento
    2015-04-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135821
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    Complaints of difficulties to attach the anatomical shoulder rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). this has the potential for delay in surgery.
  • Acción
    On 3/18/2015, URGENT MEDICAL DEVICE RECALL Notification - LOT SPECIFIC letters were sent to the affected distributors with instructions for locating, quarantining, and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.

Device

Device Recall Zimmer Anatomical Shoulder Handle for Rasp
  • Modelo / Serial
    Lot Number(s):  13870129 &  13878179.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.
  • Descripción del producto
    Anatomical Shoulder Handle for Rasp || Item: 01.04233.000 || Used during total joint arthroplasty of the shoulder.
  • Manufacturer
    Zimmer Gmbh

Manufacturer

Zimmer Gmbh
  • Dirección del fabricante
    Zimmer Gmbh, Sulzer Allee 8, Winterthur Switzerland
  • 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