Events

Retiro De Equipo (Recall) de Device Recall Construx Alum Ankle Clamp

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
    71255
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1741-2015
  • Fecha de inicio del evento
    2015-05-01
  • Fecha de publicación del evento
    2015-06-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137058
  • 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
    Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
  • Causa
    Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. this prevents complete range of motion and if pushed too far may loosen the pin from the bone. a revision surgery may be necessary to adequately reconnect the fixator to the bone.
  • Acción
    Biomet sent an URGENT MEDICAL DEVICE RECALL NOTICE letter dated May 1, 2015 to the affected distributors and implanting surgeons. The recall letter included a description of the reason for the recall, affected product, consignee responsibilities, and distributor instructions for responding to the formal recall notification. Consignees were instructed to return the affected product and continued monitoring of patients. 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 Construx Alum Ankle Clamp
  • Modelo / Serial
    Part 14-450510 Lots:268000, 466170, and 813950
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution in the states of CA, TX, FL, NC, MI, GA.
  • Descripción del producto
    Unilateral external fixation ankle clamp || Product Usage: || Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality
  • 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