Events

Retiro De Equipo (Recall) de Bone Plate

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
    61207
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1286-2012
  • Fecha de inicio del evento
    2010-04-26
  • Fecha de publicación del evento
    2012-03-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107560
  • 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
    Plate, bone - Product Code JEY
  • Causa
    On 4/26/10 biomet microfixation, jacksonville, fl initiated a recall of their 1.5 3/3 hole 100 degree left x-long l plate, model #01-7036, lot #193690. product is labeled incorrectly.
  • Acción
    Biomet Microfixation, LLC sent an Urgent Medical Device Safety Alert letter dated April 21, 2010 to all consignees affected. Each consignee was notified by E-mail, letter or telephone call the week of April 26, 2010. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to fill out the attached Inventory Reconciliation sheet and FAX it to the attention of the Global Complaint Coordinator at 904-741-9425. If the affected product have been further distribute, consignees are instructed to notify the recipient of this action by providing the recipient a copy of this notice. This letter must be given to the personnel responsible for receiving field action notices. For questions contact Christy Cain at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.

Device

Bone Plate
  • Modelo / Serial
    Lot 193690
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    USA Nationwide Distribution including the states of: California and Texas.
  • Descripción del producto
    Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE, QTY 00001, CE 0086, 2010-04 *** NON-STERILE PRODUCT ***, LEFT, X-LONG, 0.6 MM TITANIUM, BIOMET MICROFIXATION, 1540 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, 01-736, LOT 999999, QTY 00001, L-SHAPE, 3 X 3 HOLE, 100 DEGREE, LEFT, X-LONG, 0.6 MM, CE 0086.***" || Product Usage - CTS Usage: || Bone-plate - internal fixation devices intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
  • 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