Events

Retiro De Equipo (Recall) de Device Recall Tytin Regular Set

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 Kerr Corporation.

¿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
    68426
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1788-2014
  • Fecha de inicio del evento
    2014-05-29
  • Fecha de publicación del evento
    2014-06-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127565
  • 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
    Alloy, amalgam - Product Code EJJ
  • Causa
    Kerr corporation is recalling one (1) lot of tytin regular set ( part number 29948, lot number 3-1294), because it may set faster than specified in the directions for use.
  • Acción
    Kerr Corporation initiated this recall by sending the recall notification letter accompanied by a return form, to customers via USPS 1st class mail. The consignees are instructed to complete the return form and return any affected product to Kerr Corporation. The recall notification letter, dated May 29, 2014, titled "URGENT: MEDICAL DEVICE RECALL", informed customers of the recall by providing the following information: product description with part number and lot number, distribution date range, reason for recall, risk statement, instructions to customers and/or Kerr distributor on what to do with the recalled product, FDA MEDWATCH reporting system info, and company contact information, and instructed customers to complete the return form titled "Acknowledgement and Recall Return Form".

Device

Device Recall Tytin Regular Set
  • Modelo / Serial
    Part Number 29948, Lot Number 3-1294. Expires October 2016
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, Australia, Belgium, Czech Republic, Germany, Spain, France, Great Britain, French Guiana, Italy, Portugal, and Saudi Arabia.
  • Descripción del producto
    Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. || The intended use of this device is to be used as a dental restorative material in the treatment of dental caries.
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation
  • Dirección del fabricante
    Kerr Corporation, 28200 Wick Rd, Romulus MI 48174-2639
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA