Events

Retiro De Equipo (Recall) de Lateral Decubitus Alignment Guide

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 Stryker Howmedica Osteonics Corp..

¿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
    52375
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1817-2009
  • Fecha de inicio del evento
    2006-04-27
  • Fecha de publicación del evento
    2009-08-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-10-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82807
  • 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
    Impactor - Product Code HWA
  • Causa
    The lateral decubitus alignment guide either did not assemble to its mating part, the curved impaction handle, or partially engages the handle, but does not fully lock.
  • Acción
    Important Market Withdrawal Letters were sent to Stryker Branches on April 27, 2006 vis Federal Express. The letter asked consignees to examine their inventory and identify the product. They are to retrieve all affected product lots and return to their branch or agency warehouse for reconciliation. Also, they are to reconcile all product on the attached Product Accountability Form and fax a copy. Affected should be returned and their Stryker Orthopaedics Customer Service Rep should be contacted to re-order the product that is being returned as part of this recall. Questions should be referred to Rita Intorella at 201-831-5825.

Device

Lateral Decubitus Alignment Guide
  • Modelo / Serial
    Lot codes: TACFA03, TACFA0G, TACFA0M, TACF12P, & TACG104.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Lateral Decubitus Alignment Guide, Non Sterile; manual surgical instrument. The MIS Hip Acetabular instrument set includes the curved positioner/impactor, supine alignment guide, and decubitus alignment guide. || Catalog No. 1440-1370 || Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. || Authorized Representative in Europe: Stryker France, Cedex France. || The correct position of the cup relative to the pelvic reference planes can be achieved by the use of the alignment guide.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Dirección del fabricante
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA