Events

Retiro De Equipo (Recall) de Device Recall Orthopedic Manual Surgical Instrument

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
    73258
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0885-2016
  • Fecha de inicio del evento
    2016-02-16
  • Fecha de publicación del evento
    2016-02-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143636
  • 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
    A complaint was received where the hiploc plate/lag screw introducer was undersized and would not accept the introducor coupling screw. it appears now that not all parts manufactured to rev a drawing were reworked.
  • Acción
    Biomet sent an " URGENT MEDICAL DEVICE RECALL NOTICE" dated February 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The following actions are REQUIRED: Immediately locate and remove the identified device(s) listed below from circulation. Remove the affected product from circulation. Review this notification and ensure that all affected personnel are aware of its contents. Carefully follow the instructions on the enclosed Response Form. Email a copy of the response form to CPWARFieldAction@zimmerbiomet.com prior to return of product. You do not need to complete the Biomet UK response form. Use priority carrier for your shipment. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: "Online: www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or "Call (800)FDA-1088 Thank you in advance for your assistance and prompt attention. On behalf of Zimmer Biomet, I apologize for any inconvenience this may cause. 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 Orthopedic Manual Surgical Instrument
  • Modelo / Serial
    Catalog Number: 35-000263; and Lot Number Identification: 1807188, 1807189, 1943563, and 2577847.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : MO, UT, AZ, IL, PA, KY, MI, NC, NJ, MN and GA., and Internationally to The Netherlands.
  • Descripción del producto
    HipLOC CHS Plate/Lag Screw Introducer
  • 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