Retiro De Equipo (Recall) de Device Recall Optilock, Locking Screw 3.5mm x 28mm

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 Biomet, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Plate, fixation, bone - Product Code HRS
  • Causa
    Biomet initiated this action after a complaint was received that item 36728, non-locking screw 3.5mm x 28mm was in a package labeled as 37728, locking screw 3.5mm x 28mm.
  • Acción
    A March 15 2012 Urgent Medical Device Recall Notice was sent to Distributors, Operating Room Managers, and Physicians with directions to locate and remove recalled items with instructions to provide the recall notice to any sub-accounts. The letter also identified the affected product and explained the reason for the recall. OR Managers and Physicians are to confirm recall notice receipt by calling 800-348-9500, extention 3983 or 3009 and make arrangements for product return. Distributors are to complete and FAX back the response tracking form to the attention of Angi Dickson, Biomet @ 574-372-1638. Questions should be directed to 574-372-3983 or 574-371-3009 M- F, 8 AM- 5 PM, (ET).


  • Modelo / Serial
    Item 37728, Lot 989520; Lot 850910 ; Lot 091250   Lot 429270
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution -- USA, including NJ, TX, VA, MI IL, KT, & Puerto Rico, and country of the Netherlands.
  • Descripción del producto
    Optilock, Locking Screw 3.5 mm x 28 mm, non sterile, REF 37728, Biomet Trauma Parsippany, NJ 97054. || Cortical Locking Screw for securing a Proximal Humeral Plate to the bone in the Optilock system.
  • Manufacturer


  • Dirección del fabricante
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Empresa matriz del fabricante (2017)
  • 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