Events

Retiro De Equipo (Recall) de Device Recall OsseoFix 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 Implant Innovations, 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
    26370
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0924-03
  • Fecha de inicio del evento
    2003-05-09
  • Fecha de publicación del evento
    2003-06-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27575
  • 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
    Implant, Endosseous, Root-Form - Product Code DZE
  • Causa
    Some 8mm osseofix drills may be incorrectly laser marked as 4mm osseofix drills.
  • Acción
    The firm faxed and e-mailed a recall communication to international accounts on 5/9/2003 and mailed recall letters to domestic accounts on 5/12/2003. The firms were requested to examine their stock and return product as well as to notify any subaccounts of the recall and recover and return their products. Letters to specific consignees only listed the recalled lot numbers that were shipped to that consignee. A response form was included and was to be faxed back to the recalling firm.

Device

Device Recall OsseoFix System
  • Modelo / Serial
    lot numbers 127726 and 191427
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide & France, Japan, Spain, Germany, Korea, Australia, Argentina, Denmark, Chile, England, Brazil.
  • Descripción del producto
    Products are surgical drills packaged separately or included in a surgical kit so two products will be listed. || The second product is the 8mm drill included in a kit and It is labeled as OFKIT2 OsseoFix System Complete (Kit)3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL 33410 Non Sterile Contents must be sterilized prior to use. RX only.
  • Manufacturer
    Implant Innovations, Inc.

Manufacturer

Implant Innovations, Inc.
  • Dirección del fabricante
    Implant Innovations, Inc., 4555 Riverside Dr, Palm Beach Gardens FL 33410
  • Source
    USFDA