Events

Retiro De Equipo (Recall) de Device Recall Moore & Thompson Hip Stems

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 Zimmer, 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
    68818
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2551-2014
  • Fecha de inicio del evento
    2014-07-22
  • Fecha de publicación del evento
    2014-08-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129075
  • 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
    Prosthesis, hip, femoral component, cemented, metal - Product Code JDG
  • Causa
    Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
  • Acción
    Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice.

Device

Device Recall Moore & Thompson Hip Stems
  • Modelo / Serial
    Item Numbers:00400500038, 00400500040, 00400500041, 00400500042, 00400500043, 00400500044, 00400500045, 00400500046, 00400500047, 00400500048, 00400500049, 00400500050, 00400500051, 00400500052, 00400500053, 00400500054, 00400500055, 00400500057, 00400500060, 00400500063, 00400600038, 00400600040, 00400600041, 00400600042, 00400600043, 00400600044, 00400600045, 00400600046, 00400600047, 00400600048, 00400600049, 00400600050, 00400600051, 00401000038, 00401000040, 00401000041, 00401000042, 00401000043, 00401000044, 00401000045, 00401000046, 00401000047, 00401000048, 00401000049, 00401000050, 00401000051, 00401000052, 00401000053, 00401000054, 00401000055,, 00401000057, 00401000060, 00401000063, 00402200038, 00402200040, 00402200041, 00402200042, 00402200043, 00402200044, 00402200045, 00402200046, 00402200047, 00402200048, 00402200049, 00402200050, 00402200051, 00402200052, 00402200053, 00402200054, 00402200055, 00402200057, 00402200060, 00402200063, 00402300038, 00402300041, 00402300043, 00402300044, 00402300046, 00402300048, 00402300049, 00402300051, 30400500038, 30400500040, 30400500041, 30400500042, 30400500043, 30400500044, 30400500045, 30400500046, 30400500047, 30400500048, 30400500049, 30400500050, 30400500051, 30400500052, 30400500053, 30400500054, 30400500055, 30400500057, 30400500060, 30400500063, 30402200038, 30402200040, 30402200041, 30402200042, 30402200043, 30402200044, 30402200045, 30402200046, 30402200047, 30402200048, 30402200049, 30402200050, 30402200051, 30402200052, 30402200053, 30402200054, 30402200055, 30402200057, 30402200060, 30402200063   EXPIRATION DATE PRIOR TO 2024-07
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Moore & Thompson Hip Stems: || FNSTRD HIP 38HDX127ST || FNSTRD HIP 40HDX127ST || FNSTRD HIP 41HDX127ST || FNSTRD HIP 42HDX127ST || FNSTRD HIP 43HDX127ST || FNSTRD HIP 44HDX127ST || FNSTRD HIP 45HDX140ST || FNSTRD HIP 46HDX140ST || FNSTRD HIP 47HDX140ST || FNSTRD HIP 48HDX140ST || FNSTRD HIP 49HDX140ST || FNSTRD HIP 50HDX152ST || FNSTRD HIP 51HDX152ST || FNSTRD HIP 52HDX152ST || FNSTRD HIP 53HDX152ST || FNSTRD HIP 54HDX152ST || FNSTRD HIP 55HDX152ST || FNSTRD HIP 57HDX152ST || FNSTRD HIP 60HDX152ST || FNSTRD HIP 63HDX152ST || FNSTRD HIP 38HDX140ST || FNSTRD HIP 40HDX140ST || FNSTRD HIP 41HDX140ST || FNSTRD HIP 42HDX140ST || FNSTRD HIP 43HDX140ST || FNSTRD HIP 44HDX140ST || FNSTRD HIP 45HDX152ST || FNSTRD HIP 46HDX152ST || FNSTRD HIP 47HDX152ST || FNSTRD HIP 48HDX152ST || FNSTRD HIP 49HDX152ST || FNSTRD HIP 50HDX152ST || FNSTRD HIP 51HDX152ST || HIP PROS 38HDX105ST || HIP PROS 40HDX105ST || HIP PROS 41HDX105ST || HIP PROS 42HDX105ST || HIP PROS 43HDX105ST || HIP PROS 44HDX105ST || HIP PROS 45HDX105ST || HIP PROS 46HDX105ST || HIP PROS 47HDX105ST || HIP PROS 48HDX105ST || HIP PROS 49HDX105ST || HIP PROS 50HDX105ST || HIP PROS 51HDX105ST || HIP PROS 52HDX105ST || HIP PROS 53HDX105ST || HIP PROS 54HDX105ST || HIP PROS 55HDX105ST || HIP PROS 57HDX105ST || HIP PROS 60HDX105ST || HIP PROS 63HDX105ST || FNSTRD HIP 38HDX165ST || FNSTRD HIP 40DX165ST || FNSTRD HIP 41HDX165ST || FNSTRD HIP 42HDX165ST || FNSTRD HIP 43HDX165ST || FNSTRD HIP 44HDX165ST || FNSTRD HIP 45HDX165ST || FNSTRD HIP 46HDX165ST || FNSTRD HIP 47HDX165ST || FNSTRD HIP 48HDX165ST || FNSTRD HIP 49HDX165ST || FNSTRD HIP 50HDX191ST || FNSTRD HIP 51HDX191ST || FNSTRD HIP 52HDX191ST || FNSTRD HIP 53HDX191ST || FNSTRD HIP 54HDX191ST || FNSTRD HIP 55HDX191ST || FNSTRD HIP 57HDX191ST || FNSTRD HIP 60HDX191ST || FNSTRD HIP 63HDX191ST || FNSTRD HIP 38HDX165ST || FNSTRD HIP 41HDX165ST || FNSTRD HIP 43HDX165ST || FNSTRD HIP 44HDX165ST || FNSTRD HIP 46HDX165ST || FNSTRD HIP 48HDX165ST || FNSTRD HIP 49HDX165ST || FNSTRD HIP 51HDX165ST || HIP PROS 38HDX127ST || HIP PROS 40HDX127ST || HIP PROS 41HDX127ST || HIP PROS 42HDX127ST || HIP PROS 43HDX127ST || HIP PROS 44HDX127ST || HIP PROS 45HDX140ST || HIP PROS 46HDX140ST || HIP PROS 47HDX140ST || HIP PROS 48HDX140ST || HIP PROS 49HDX140ST || HIP PROS 50HDX152ST || HIP PROS 51HDX152ST || HIP PROS 52HDX152ST || HIP PROS 53HDX152ST || HIP PROS 54HDX152ST || HIP PROS 55HDX152ST || HIP PROS 57HDX152ST || HIP PROS 60HDX152ST || HIP PROS 63HDX152ST || HIP PROS 38HDX165ST || HIP PROS 40HDX165ST || HIP PROS 41HDX165ST || HIP PROS 42HDX165ST || HIP PROS 43HDX165ST || HIP PROS 44HDX165ST || HIP PROS 45HDX165ST || HIP PROS 46HDX165ST || HIP PROS 47HDX165ST || HIP PROS 48HDX165ST || HIP PROS 49HDX165ST || HIP PROS 50HDX191ST || HIP PROS 51HDX191ST || HIP PROS 52HDX191ST || HIP PROS 53HDX191ST || HIP PROS 54HDX191ST || HIP PROS 55HDX191ST || HIP PROS 57HDX191ST || HIP PROS 60HDX191ST || HIP PROS 63HDX191ST
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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
    USFDA