Events

Retiro De Equipo (Recall) de K-WIRES WITH WIRE GUIDES - STAINLESS STEEL

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por OSTEK ORTHOPAEDICS 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
    135653
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-01-21
  • 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
    These products with the listed lot numbers are being removed from the marketplace due to a concern with the inner sterile pouch sealing of the product and to assure that affected product is inspected before it is used in a sterile surgical procedure.

Device

K-WIRES WITH WIRE GUIDES - STAINLESS STEEL
  • Modelo / Serial
    Model Catalog: 1600-023 (Lot serial: > 10 numbers contact mfg); Model Catalog: 1600-022 (Lot serial: > 10 numbers contact mfg); Model Catalog: 1600-021 (Lot serial: > 10 numbers contact mfg); Model Catalog: 1600-020 (Lot serial: MORE THAN 10 PLS CONTACT MFG); Model Catalog: 1600-023 (Lot serial: MORE THAN 10 PLS CONTACT MFG); Model Catalog: 1600-022 (Lot serial: MORE THAN 10 PLS CONTACT MFG); Model Catalog: 1600-021 (Lot serial: MORE THAN 10 PLS CONTACT MFG); Model Catalog: 1600-020 (Lot serial: > 10 numbers contact mfg); Model Catalog: 1620-509 (Lot serial: 0413219296); Model Catalog: 1620-109 (Lot serial: 0413219296); Model Catalog: 1648-609 (Lot serial: MORE THAN TEN PLS CONTACT MFG); Model Catalog: 1648-509 (Lot serial: MORE THAN TEN PLS CONTACT MFG); Model Catalog: 1640-509 (Lot serial: MORE THAN TEN PLS CONTACT MFG); Model Catalog: 1636-509 (Lot serial: MORE THAN TEN PLS CONTACT MFG); Model Catalog: 1632-609 (Lot serial: MORE THAN TEN PLS CONTACT MFG); Model Catalog: 1632-509 (Lot serial: MORE THAN TEN
  • Descripción del producto
    K-WIRES WITH WIRE GUIDES - STAINLESS STEEL
  • Manufacturer
    OSTEK ORTHOPAEDICS INC.

Manufacturer

OSTEK ORTHOPAEDICS INC.
  • Dirección del fabricante
    OAKVILLE
  • Source
    HC