Events

Retiro De Equipo (Recall) de Stryker Orthopaedics

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
    72498
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0362-2016
  • Fecha de inicio del evento
    2015-09-21
  • Fecha de publicación del evento
    2015-12-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141277
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    Stryker orthopaedics has received two customer complaints regarding duracon tibial wedge implants puncturing the packaging's tyvek lid(s).
  • Acción
    On September 18, 2015, Stryker notified their Branches/Agencies of their action via email. The Branches/Agencies were instructed to quarantine affected devices. Urgent Medical Device Recall Notification Letters/Urgent Medical Device Recall Notification Acknowledgement Forms dated September 21, 2015 were sent to Branches/Agencies via UPS on 9/21/2015. Urgent Medical Device Recall Notification Letters/Urgent Medical Device Recall Notification Acknowledgement Forms dated September 21, 2015 were sent to Hospital Risk Managers via UPS on 9/23/2015. The notification instructed consignees on how to identify affected product; the related issue with the affected product; potential hazards; risk mitigations; and actions needed to be taken. Consignees were asked to contact their Stryker Orthopaedics Sales Representative to arrange for return of any recalled product. Customers were asked to complete and return the attached Product Recall Acknowledgement Form within 5 days and either email (strykerortho7984@stericycle.com or Fax (1-866-672-0627) the response form back. A point of contact was provided in case the customer had any questions 201.831.5826.

Device

Stryker Orthopaedics
  • Modelo / Serial
    Multiple Lot Numbers. Catalog Numbers: 6630-6-105, 6630-6-110, 6630-6-125, 6630-6-130, 6630-6-150, 6630-6-155, 6630-6-170, 6630-6-175, 6630-6-205, 6630-6-210, 6630-6-225, 6630-6-230, 6630-6-250, 6630-6-255, 6630-6-270, 6630-6-275, 6630-6-305, 6630-6-310, 6630-6-325, 6630-6-330, 6630-6-350, 6630-6-355, 6630-6-370, 6630-6-375, 6630-6-405, 6630-6-410, 6630-6-425, 6630-6-430, 6630-6-450, 6630-6-455, 6630-6-470 and 6630-6-475.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed US (nationwide) and the countries of Australia, Canada, Germany, Hong Kong, Italy, Japan, Malaysia, New Zealand, Netherlands, Poland, Romania, Spain, Sweden and Switzerland.
  • Descripción del producto
    Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended to be used with the Universal tibial baseplate to augment bone loss on the surface of the tibia.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Dirección del fabricante
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA