Events

Retiro De Equipo (Recall) de Device Recall Holding Forceps for Trident 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 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
    52384
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0539-2010
  • Fecha de inicio del evento
    2007-01-24
  • Fecha de publicación del evento
    2009-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-12-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82817
  • 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
    Forceps - Product Code HTD
  • Causa
    The tips of the forceps were larger than the positioning holes located on the trials and the implant liners.
  • Acción
    Important Product Correction letters, dated January 24, 2007, were sent to all consignees on via Federal Express. The letter stated the problem and asked customers to examine their inventory and hospital locations to identify the affected product. All affected forceps product should be retrieved from hospitals and returned to their branch or agency warehouse for reconciliation. Customers are also to reconcile all affected product on the attached Product Accountability Form and fax a copy of that form to 201-831-6069 within 5 days of receipt of the letter. All affected forceps product is to be destroyed and discarded at their branch location. Questions should be directed to their Stryker Orthopaedics Customer Service rep at 1-866-OR-ASSIST.

Device

Device Recall Holding Forceps for Trident Acetabular System
  • Modelo / Serial
    All lots beginning with V1 (XXX).
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- Including countries of Hong Kong, Australia, Japan, New Zealand, Hong Kong, Singapore, Germany, Sweden, The Netherlands, France, Spain, Portugal, and the United Kingdom.
  • Descripción del producto
    Holding Forceps for Trident Acetabular System; non Sterile; || Catalog number 2105-0000; || Howmedica Osteonics Corp, 325 Corporate Drive, || Mahwah, NJ 07430; || Authorized representative in Europe: || Stryker France, Cedex. France || The Holding Forceps for Acetabular trial cups help facilitate the insertion / correction of the Acetabular trial inserts.
  • 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