Events

Retiro De Equipo (Recall) de Zimmer Trabecular Metal Modular Acetabular System

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
    59503
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3279-2011
  • Fecha de inicio del evento
    2011-09-01
  • Fecha de publicación del evento
    2011-09-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102997
  • 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
    Prothesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
  • Causa
    Lot # 61132698 and lot 001122467 (added 9/ 18/2012) may have a manufacturing non conformance that could prevent the devices from functioning as intended. specifically, devices in the affected lot may have a locking ring groove depth that prevents the corresponding liner from snapping into the shell. the groove provides the locking ring room to displace when inserting a liner into the shell. th.
  • Acción
    Zimmer, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated July 27, 2011 to all affected customers of lot 61132698 and 9/18/2012 to only affected customer of lot 001122467. The letters describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to stop using and to quarantine the affected product. An Inventory Return Certification Form was included with the letter for customers to complete and return to Zimmer, Inc. via fax at (574) 372-4265. Replacement product will be provided for all returned product. Contact Zimmer, Inc. at 1-800-613-6131 for questions regarding this recall.

Device

Zimmer Trabecular Metal Modular Acetabular System
  • Modelo / Serial
    Part 00-6202-052-21, Lot 61132698 and lot 001122467
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of CA, NC,NY, PA, WA, and WI and countries of Australia, Germany, The Netherlands, and Switzerland.
  • Descripción del producto
    The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional screws. The Shells are available in a variety of sizes and are designed to be used with Trilogy Acetabular System liners. The shell implants are used to replace the hip socket during total hip arthroplasty. || The device is indicated for primary or revision surgery for rehabilitating hips damaged as a result on noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis,protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant. The device is intended for either cemented or noncemented use.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Dirección del fabricante
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA