Events

Retiro De Equipo (Recall) de Device Recall Optigun Ratchet

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 BIOMET FRANCE S.A.R.L..

¿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
    71365
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1744-2015
  • Fecha de inicio del evento
    2015-05-14
  • Fecha de publicación del evento
    2015-06-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137454
  • 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
    Dispenser, cement - Product Code KIH
  • Causa
    The pin which maintains the knob button, may disconnect and become lost. this may result in a delay of surgery to obtain a new optigun and detect/retrieve the pin, and may necessitate revision surgery if the pin falls into the surgical site and is not detected.
  • Acción
    BIOMET sent an URGENT ADVISORY NOTICE dated May 14, 2015, to all affected customers via courier. 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. Customers were instructed to check the product to identify to determine if the pin is defective, if defective they should return it to Biomet Warsaw, following the directions on the Response Form and confirm receipt of the notice by sending back the response form. Questions related to this notice should be directed to (574) 372- 1570 Monday through Friday 8 a.m. to 5 p.m.

Device

Device Recall Optigun Ratchet
  • Modelo / Serial
    Catalog number: 419500 Lot number: 0101296012
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution to MD only
  • Descripción del producto
    The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.
  • Manufacturer
    BIOMET FRANCE S.A.R.L.

Manufacturer

BIOMET FRANCE S.A.R.L.
  • Dirección del fabricante
    BIOMET FRANCE S.A.R.L., plateau de lautagne, valence cedex 9, Valence Cedex 9 France
  • 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