Events

Retiro De Equipo (Recall) de Security Enclosed Carpal Tunnel Security Blade

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, 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
    66792
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0381-2014
  • Fecha de inicio del evento
    2013-10-25
  • Fecha de publicación del evento
    2013-11-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123472
  • 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
    Guide, surgical, instrument - Product Code FZX
  • Causa
    Security blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating security clip.
  • Acción
    10/25/2013 Urgent Medical Device Recall Notifications were sent to each Distributor and Risk/Recall Manager at each direct account identifying the recalled device, possible adverse health consequences and instructing consignees to immediately locate and remove devices from circulation, following instructions on the FAX back form and returning it within 3 business days to FAX 574-372-1683 and returning product to Biomet Return Goods, 56 East Bell Drive Warsaw In 46580. Questions should be directed to 574-372-1570 M-F, 8 a.m. to 5 p.m.

Device

Security Enclosed Carpal Tunnel Security Blade
  • Modelo / Serial
    Catalog Number: 200068 Medical Device Listing Number: B008657 Lot Number Identification: 088610, 090600, 143810, 257060, 289900, 365910, 460490, 558300, 626660, 697320,767260,795090,857730,864640,979680
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA (nationwide) and Internationally to Japan.
  • Descripción del producto
    REF 200068 Security (TM) Enclosed Carpal Tunnel System || Blade ( Single) ABS /Stainless Steel || Sterile Device, Single Use Only. || Designed to release the transverse carpal ligament.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Dirección del fabricante
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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