Events

Retiro De Equipo (Recall) de COBALT CHROME MODULAR HEAD COMPONENT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BIOMET CANADA 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
    32864
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-05-05
  • 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
    An internal non-conformance discovered by biomet china reported that the gtin codes on the outer labels of various biomet orthopedics products are incorrect. there were 2 complaints describing the incorrect gtin codes.

Device

COBALT CHROME MODULAR HEAD COMPONENT
  • Modelo / Serial
    Model Catalog: 163668 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 163667 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 163669 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 163670 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 11-104211 (Lot serial: 349650); Model Catalog: 11-104212 (Lot serial: 182030); Model Catalog: 11-104211 (Lot serial: 182030); Model Catalog: 11-104212 (Lot serial: 127340); Model Catalog: 11-104211 (Lot serial: 127340); Model Catalog: 11-104212 (Lot serial: 349650); Model Catalog: 141316 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 141318 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 141320 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 141314 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 163674 (Lot serial: 453220); Model Catalog: 113644 (Lot serial: NA)
  • Descripción del producto
    BIOMET HIP SYSTEM MODULAR HEAD COMPONENT-STANDARD
  • Manufacturer
    BIOMET CANADA INC.

Manufacturer

BIOMET CANADA INC.
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    HC