Events

Retiro De Equipo (Recall) de Device Recall Endosseous Dental Implant Accessories

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 Dental 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
    77911
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3208-2017
  • Fecha de inicio del evento
    2017-07-10
  • 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=158316
  • 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
    Accessories, implant, dental, endosseous - Product Code NDP
  • Causa
    Zimmer biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard ifus. all the products were missing supplemental ifus.
  • Acción
    The affected customers are being provided instructions on how to obtain the supplemental IFUs for respective part numbers from appropriate E-labeling website along with a recall notice.

Device

Device Recall Endosseous Dental Implant Accessories
  • Modelo / Serial
    lot # 63275811, 63238369, 63286562, 63240994, 63250273, 63286560, 62556219, 62607124, 62675252, 62445681, 62086170, 62679151, 62734003
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
  • Descripción del producto
    IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; || MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; || IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; || IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S; || IMPRESSION CAP,CONT,5.5MM, ANG, REF ZOCIMP5A; || IMPRESSION CAP, CONT, 5.5MM, REF ZOCIMP5S; || MPRESSION CAP, CONT, 6.5MM,ANG, REF ZOCIMP6A; || IMPRESSION CAP, CONT, 6.5MM, REF ZOCIMP6S
  • Manufacturer
    Zimmer Dental Inc

Manufacturer

Zimmer Dental Inc
  • Dirección del fabricante
    Zimmer Dental Inc, 1900 Aston Ave, Carlsbad CA 92008-7308
  • 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