Events

Retiro De Equipo (Recall) de Artificial Ligament Fixation Device 15mm, 20mm, 25mm, 30mm, & 35mm TI NS Toggleloc; & 7 PE Ziploop

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 Sports Medicine.

¿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
    48745
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0582-2012
  • Fecha de inicio del evento
    2008-04-24
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72047
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • Causa
    Six sizes of toggleloc, artificial ligament fixation device, have been manufactured with the suture pull hole drilled in the wrong location on the device. the toggleloc implant is deployed with a suture that pulls the device through the tunnel. the hole being drilled in the wrong location will orient the device to pass through the tunnel with the angled end of the implant first. this may caus.
  • Acción
    Biomet Sports Medicine sent an "URGENT MEDICAL DEVICE REMOVAL" notice dated May 15, 2008 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The letter instructs customers to locate and discontinue use of the affected product. Customers should contact the firm at 800-535-8692 for questions related to this notice.

Device

Artificial Ligament Fixation Device 15mm, 20mm, 25mm, 30mm, & 35mm TI NS Toggleloc; & 7 PE Ziploop
  • Modelo / Serial
    Catalog Number: 904720, 904721, 904722 (x2), 904723, 904724, & 904753 Lot Number Identification: L662080, L662090, L763680 - L662100, L662110, L662120 & L705230
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of CA, FL, GA, ID, IL, IN, KS, TX, and WA, and the countries of Australia, Chile, France, Poland, The Netherlands and Turkey.
  • Descripción del producto
    Artificial Ligament Fixation Device 15MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 25MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 20MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 30MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 35MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device #7 PE Ziploop (TM) ToggleLoc (TM). || Toggleloc anchors are indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.
  • Manufacturer
    Biomet Sports Medicine

Manufacturer

Biomet Sports Medicine
  • Dirección del fabricante
    Biomet Sports Medicine, 4861 E Airport Dr, Ontario CA 91761-7819
  • 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