Events

Retiro De Equipo (Recall) de 6.5MM CANNULATED SCREW

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    60309
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-03-11
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    It was reported that affected labelling (technique guides j2455 and j3270) may contain information regarding the use of some cannulated cortex and cancellous screws that do not match the cleared indications for use in canada. all affected labelling will be corrected to include only the correct indications.

Device

6.5MM CANNULATED SCREW
  • Modelo / Serial
    Model Catalog: 208.404 (Lot serial: N/A); Model Catalog: 208.403 (Lot serial: N/A); Model Catalog: 208.402 (Lot serial: N/A); Model Catalog: 208.401 (Lot serial: N/A); Model Catalog: ALL PART NUMBERS (Lot serial: N/A); Model Catalog: 208.480-208.487 (Lot serial: N/A); Model Catalog: 208.47-208.479 (Lot serial: N/A); Model Catalog: 208.46-208.469 (Lot serial: N/A); Model Catalog: 208.455 (Lot serial: N/A); Model Catalog: 208.454 (Lot serial: N/A); Model Catalog: 208.453 (Lot serial: N/A); Model Catalog: 208.452 (Lot serial: N/A); Model Catalog: 208.451 (Lot serial: N/A); Model Catalog: 208.450 (Lot serial: N/A); Model Catalog: 208.448 (Lot serial: N/A); Model Catalog: 208.447 (Lot serial: N/A); Model Catalog: 208.446 (Lot serial: N/A); Model Catalog: 208.445 (Lot serial: N/A); Model Catalog: 208.444 (Lot serial: N/A); Model Catalog: 208.443 (Lot serial: N/A); Model Catalog: 208.442 (Lot serial: N/A); Model Catalog: 208.449 (Lot serial: N/A); Model Catalog: 208.441 (Lot serial: N/A); Model Catalog: 208.440 (Lo
  • Descripción del producto
    6.5MM CANNULATED SCREW;CANNULATED SCREW;7.0MM CANNCELLOUS SCREW;4MM TI CANNULATED SCREW SHORT THREAD;4.5MM CANN SCREW PAR. THRD.;3.5/4.0 MM CANNULATED SCREW IMPLANT SET AND INSTRUMENTS;7.3MM CANNULATED SCREW;CORTEX SCREWS (PURE TITANIUM);6.5MM TITANIUM CA
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    HC