Events

Retiro De Equipo (Recall) de Device Recall Trabecular Metal Reverse Shoulder Liner 36 mm 65 Neck Angle

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
    62540
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2215-2012
  • Fecha de inicio del evento
    2012-07-18
  • Fecha de publicación del evento
    2012-08-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111136
  • 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, shoulder, semi-constrained, metal/polymer cemented - Product Code KWA
  • Causa
    Lot specific trabecular metal (tm) reverse shoulder liner impactors are being recalled due to reports of alignment peg fractures. all lots of tm reverse shoulder liner impactors manufactured from 455 stainless steel are being retrieved, as all reported fractured instruments were manufactured with this material. the tm reverse shoulder liner impactor units that were manufactured with 13-8 stain.
  • Acción
    Zimmmer sent an Urgent Medical Device Recall letter dated July 18, 2012, to all affected customers. The letter identified the product, the problem, and thea action to be taken by the customer. Customers were instructed to inspect all TM Reverse instrument sets for affected lot(s)(instruments. If affected product was found customers were instructed to immediately place an order to backfill the identified product with Customer Service. If an instrument was was further distributed customers were to provide a copy of the Notice to ensure their customers were aware of the removal. Customers were also instructed to provide a list of all hospitals that currently use the affected product. For questions customers were instructed to call 800-348-2759. For questions regarding this recall call 574-371-1689.

Device

Device Recall Trabecular Metal Reverse Shoulder Liner 36 mm 65 Neck Angle
  • Modelo / Serial
    Part 00-4309-029-01: Lot 60535162, 60545338, 60576488,  60605855, 60637022, 60689253, 60772974, 60875277, 60918060, 60989817, 61011689, 61024161, and 61051024.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Germany, Belgium, Denmark, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland, and the United Kingdom.
  • Descripción del producto
    00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angle || Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then, place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet."
  • Manufacturer
    Zimmer, Inc.

Manufacturer

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