Events

Retiro De Equipo (Recall) de Device Recall Smooth Guide Wire Bullet Tip, 3.0 mm Diameter, 100 cm Length; Item Number: 47225500801

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 Zimmer 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
    79681
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1473-2018
  • Fecha de inicio del evento
    2018-03-26
  • 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=162979
  • 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
    Potential failure of sterile packaging seal.
  • Acción
    Zimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy. All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018. " Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory. " Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter. " Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form. o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided.

Device

Device Recall Smooth Guide Wire Bullet Tip, 3.0 mm Diameter, 100 cm Length; Item Number: 4722550...
  • Modelo / Serial
    Lot Numbers:  63619923 63625354 63625355 63625356 63631736 63631737 63638178 63638179 63638180 63638181 63639395 63639396 63639397 63639398 63639399 63639401 63645656 63645657 63645658 63645659 63648799 63648801 63648802 63648803 63650117 63650118 63651633 63651634 63651635 63656843 63662543 63662544 63662545 63662546 63662547 63668702 63668703 63668721 63675676 63675677 63681732 63681733 63681734 63681735 63690182 63690183 63690184 63690185 63696959 63696960 63696961 63705243 63705244 63705245 63705246 63709167 63709168 63709169 63709170 63715687 63715688 63721372 63721373 63721374 63721375 63731172 63731173 63731174 63731175 63733047 63733048 63764548 63771161 63771162 63780124 63780125 63781880 63803593 63812301 63796536 63796537
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
  • Descripción del producto
    Smooth Guide Wire Bullet Tip || 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Dirección del fabricante
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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