Events

Retiro De Equipo (Recall) de Zimmer M/DN Intramedullary Fixation Metaphyseal/Diaphyseal Nail System

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, 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
    71243
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1694-2015
  • Fecha de inicio del evento
    2015-04-29
  • Fecha de publicación del evento
    2015-05-29
  • 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=136987
  • 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
    Screw, fixation, bone, non-spinal, metallic - Product Code NDJ
  • Causa
    The entire scope of 4.5mm cortical screws listed as compatible with the m/dn system is not compatible with the m/dn system. this has the potential to lead to a situation in which the screw would bind upon entering the nail and have to be removed during the surgery or removal of the screw after fracture healing.
  • Acción
    Zimmer sent an Urgent Medical Device Recall letter dated April, 29, 2015, to all affected customers.On 4/29/2015. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate all affected product and quarantine them immediately. Return the recalled product along with completed Inventory Return Certification Form. Notify Zimmer of any further distribution of the affected product. In addition, identify the surgeons and hospitals that you have identified using the provided spreadsheet. For further questions call the customer call center at 1-877-946-2761.

Device

Zimmer M/DN Intramedullary Fixation Metaphyseal/Diaphyseal Nail System
  • Modelo / Serial
    All lots. Part numbers: 00-2253-020-45  INTERLOCKING IM SCREW 4.5MM DIA X 20MM 00-2253-022-45  INTERLOCKING IM SCREW 4.5MM DIA X 22.5MM 00-2253-025-45  INTERLOCKING IM SCREW 4.5MM DIA X 25MM 00-2253-027-45  M/DN Intramedullary Fixation 4.5mm Dia. Cortical Screw 00-2253-030-45 INTERLOCKING IM SCREW 4.5MM DIA X 30MM 00-2253-032-45  INTERLOCKING IM SCREW 4.5MM DIA X 32.5MM 00-2253-035-45 INTERLOCKING IM SCREW 4.5MM DIA X 35MM 00-2253-037-45 INTERLOCKING IM SCREW 4.5MM DIA X 37.5MM 00-2253-040-45 INTERLOCKING IM SCREW 4.5MM DIA X 40MM 00-2253-042-45  INTERLOCKING IM SCREW 4.5MM DIA X 42.5MM 00-2253-045-45  INTERLOCKING IM SCREW 4.5MM DIA X 45MM 00-2253-047-45  INTERLOCKING IM SCREW 4.5MM DIA X 47.5MM 00-2253-050-45  INTERLOCKING IM SCREW 4.5MM DIA X 50MM 00-2253-052-45  INTERLOCKING IM SCREW 4.5MM DIA X 52.5MM 00-2253-055-45 INTERLOCKING IM SCREW 4.5MM DIA X 55MM 00-2253-057-45 INTERLOCKING IM SCREW 4.5MM DIA X 57.5MM 00-2253-060-45  INTERLOCKING IM SCREW 4.5MM DIA X 60MM 00-2253-062-45 INTERLOCKING IM SCREW 4.5MM DIA X 62.5MM 00-2253-065-45 INTERLOCKING IM SCREW 4.5MM DIA X 65MM 00-2253-067-45  INTERLOCKING IM SCREW 4.5MM DIA X 67.5MM 00-2253-070-45 INTERLOCKING IM SCREW 4.5MM DIA X 70MM 00-2253-072-45  INTERLOCKING IM SCREW 4.5MM DIA X 72.5MM 00-2253-075-45  INTERLOCKING IM SCREW 4.5MM DIA X 75MM 00-2253-077-45  INTERLOCKING IM SCREW 4.5MM DIA X 77.5MM 00-2253-080-45 INTERLOCKING IM SCREW 4.5MM DIA X 80MM 00-2253-082-45 INTERLOCKING IM SCREW 4.5MM DIA X 82.5MM 00-2253-085-45  INTERLOCKING IM SCREW 4.5MM DIA X 85MM 00-2253-087-45  INTERLOCKING IM SCREW 4.5MM DIA X 87.5MM 00-2253-090-45  INTERLOCKING IM SCREW 4.5MM DIA X 90MM
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Canada, Brazil, Mexico, Bahamas, Nicaragua, Singapore, China, Japan, Malaysia, Taiwan, Thailand, Korea, Spain, Belgium, Switzerland, India, Germany, England, Italy, Saudi Arabia, Lebanon, Libya, United Arab Emirates, Algeria, France, United Kingdom, Canary Islands, Iraq, Jordan, Lithuania, Morocco, Macedonia, Malta, Mauritius, Serbia, Russian Federation, and Yemen.
  • Descripción del producto
    Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, 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