Events

Retiro De Equipo (Recall) de Device Recall 3.5mm X 32.5mm Cortical Screw

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 Acumed LLC.

¿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
    48468
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2155-2008
  • Fecha de inicio del evento
    2005-12-27
  • Fecha de publicación del evento
    2008-08-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-02-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71482
  • 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
    Bone fixation screw - Product Code HWC
  • Causa
    Package of 3.5mm x 32.5mm cortical screw may contain 3.5mm x 22.5mm cortical screw.
  • Acción
    The firm issued a Product Removal notification on 12-27-2005 to their customers. The notification was sent by either FAX or by e-mail. The Product Removal Notification informed their customers of the issue, asked them to remove the screws from inventory and return the screws to Acumed. A reminder notification, dated 1/20/08 was issued to customers identifying the product and the problem and requesting the product be returned.

Device

Device Recall 3.5mm X 32.5mm Cortical Screw
  • Modelo / Serial
    Lot: W24552; Expiration date: 2010-05
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution --- USA including states of CA, KY, FL, TX, OH, OR, NY, ID NJ, NE, LA, WI, UT, MO, MS, GA, AZ and countries of United Kingdom, Italy, Puerto Rico, Turkey, Spain, Japan, South Africa, and Belgium.
  • Descripción del producto
    3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm Cortical Screw... REF HCO3325-S... Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 ". || Polarus Humeral Fixation System, 3.5mm X 32.5mm Cortical Screw are packaged in a sterile inner package which are placed into an outer box. The cortical screws are used with the Polarus Locking Humeral Rod (Polarus Huemral Fixation System) for the multi-planar fixation. The screws are sold individually to support the Polarus Locking Humeral Rod systems in the field.
  • Manufacturer
    Acumed LLC

Manufacturer

Acumed LLC
  • Dirección del fabricante
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9370
  • Empresa matriz del fabricante (2017)
    Acumed Llc
  • Source
    USFDA