Events

Retiro De Equipo (Recall) de Device Recall Hard Tissue Replacement Implants

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 Microfixation, LLC.

¿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
    74798
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2751-2016
  • Fecha de inicio del evento
    2016-06-13
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148475
  • 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
    Material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction - Product Code KKY
  • Causa
    Potential sterility deficiency.
  • Acción
    Zimmer Biomet Customers were sent an Urgent Product Recall letter dated June 13, 2016, via via FedEx mail. The letter notified customers of a recall of Hard Tissue Replacement Polymer Implants due to voids in sterile packaging. The firm instructed customers to locate and discontinue use of the implants, complete the Fax Response form and fax it to 904-741-9425, send back any quarantined product using the FedEx labels provided along with the recall notification, and to notify facilities where the implant was further distributed by forwarding them a copy of the provided notice. The firm instructed distributors to forward the notice to officials of their customers who are in charge of receiving recall notices. Additionally, the firm informed distributors that they are responsible for locating and returning distributed product. Questions are to be directed to 1-800-874-7711 or 904-741-4400 x9574, Monday thru Friday from 8am to 4pm ET. Her after hours phone is 812-614-9499. For questions regarding this recall call 904-741-9225.

Device

Device Recall Hard Tissue Replacement Implants
  • Modelo / Serial
    Custom made, one per customer. Affected units were sealed between April 28, 2016 and June 7, 2016
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US including AZ, CA, FL, MO, NH, PA, TX, & VA, and Internationally to Austria, Canada, England, Germany, Greece, Italy, Netherlands, & South Africa.
  • Descripción del producto
    Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. || HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
  • Manufacturer
    Biomet Microfixation, LLC

Manufacturer

Biomet Microfixation, LLC
  • Dirección del fabricante
    Biomet Microfixation, LLC, 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 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