Events

Retiro De Equipo (Recall) de DePuy LCS Complete 3-Peg Metal Backed Patella

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por DePuy Orthopaedic Technology 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
    16347
  • Fecha de inicio del evento
    2014-03-05
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
  • Causa
    During routine inspection a dimensional discrepancy was observed that alters the mechanical lock between the polyethylene and the biteplate. due to this, we are advised that such implants had a higher risk of breakage of the polyethylene component or dissociation of the polyethylene articular surface from the baseplate.
  • Acción
    Manufacturer to issue advice regarding use

Device

DePuy LCS Complete 3-Peg Metal Backed Patella

Manufacturer

DePuy Orthopaedic Technology Inc