Events

Retiro De Equipo (Recall) de Device Recall Vanguard Universal Tibial Resection Block

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 U.K., Ltd..

¿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
    61274
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1223-2012
  • Fecha de inicio del evento
    2012-02-14
  • Fecha de publicación del evento
    2012-03-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107700
  • 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
    This recall was initiated following a report that a bag labeled as ref. 32-487557/lot no 2561334 (vanguard tibial resection head universal w/ alignment tower) actually contained a ref. 32-487002/lot no. 2561329 (vanguard distal cutting block w/out handle attachment). investigation found packaging of the affected product may contain the incorrect item.
  • Acción
    Biomet U.K. sent a Field Safety Corrective Action notice dated February 14, 2012 to all affected customers. The notice identified the affected products, problem and actions to be taken. Customers were instructed to locate, discontinue use and quarantine the recalled products pending return to Biomet. The letter recommended customers provide the notice to any other organization who may have received the affected instruments. Customers were instructed to complete and return without delay the attached "Fax-Back Response Form" acknowledging receipt of notice and indicating the quantity of products to be returned. For questions call +44 (0) 1656 761658, fax: +44 (0) 1656 645454 and e-mail uk.complaints@biomet.com

Device

Device Recall Vanguard Universal Tibial Resection Block
  • Modelo / Serial
    REF. 32-487557/ Lot no 2561334
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - in the countries of France, Japan, Italy, Netherlands, UK , no devices distributed in the USA
  • Descripción del producto
    Vanguard Knee Instrumentation Tibial Resection Tower Universal with alignment tower geometry, REF 32487557, LOT 2561334, Biomet UK Ltd, South Wales, UK || Product Usage: Usage: Used to guide a saw blade in resecting the proximal tibia. Intended to be used with a tibial alignment guide.
  • Manufacturer
    Biomet U.K., Ltd.

Manufacturer

Biomet U.K., Ltd.
  • Dirección del fabricante
    Biomet U.K., Ltd., Waterton Industrial Estate, Bridgend, South Wales United Kingdom
  • 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