Events

Retiro De Equipo (Recall) de Device Recall SCORPIO CR TIBIAL TRIAL

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
    56332
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1681-2011
  • Fecha de inicio del evento
    2010-07-13
  • Fecha de publicación del evento
    2011-03-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-09-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93258
  • 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 became aware that there is the potential for the scorpio t72 tibial insert trials to be oversized by a maximum of .024" (0.6mm).
  • Acción
    Stryker Howmedica Osteonics Corp.sent Urgent Product Correction letters Correction letters dated July 23, 2010, via Federal Express to all affected customers. were sent to all Stryker Branches on July 23, 2010 via Federal Express. Asia Pacific, Canada, Europe, Middle East, Africa, Japan and Latin America sites were sent letters on July 26, 2010 by Federal Express. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the attached Product Correction Acknowledgement Form by fax as soon as possible to 201-831-6069. For any questions customers were to call 201-972-2100 or 201-831-5028.

Device

Device Recall SCORPIO CR TIBIAL TRIAL
  • Modelo / Serial
    T72-2-0308 SCORPIO CR TIBIAL TRIAL, SIZE 3, 8 MM T72-2-0310 SCORPIO CR TIBIAL TRIAL, SIZE 3, 10 MM T72-2-0312 SCORPIO CR TIBIAL TRIAL, SIZE 3, 12 MM T72-2-0315 SCORPIO CR TIBIAL TRIAL, SIZE 3, 15 MM T72-2-0318 SCORPIO CR TIBIAL TRIAL, SIZE 3, 18 MM T72-2-0321 SCORPIO CR TIBIAL TRIAL, SIZE 3, 21 MM T72-2-0324 SCORPIO CR TIBIAL TRIAL, SIZE 3, 24 MM T72-2-0508 SCORPIO CR TIBIAL TRIAL, SIZE 5, 8 MM T72-2-0510 SCORPIO CR TIBIAL TRIAL, SIZE 5, 10 MM T72-2-0512 SCORPIO CR TIBIAL TRIAL, SIZE 5, 12 MM T72-2-0515 SCORPIO CR TIBIAL TRIAL, SIZE 5, 15 MM T72-2-0518 SCORPIO CR TIBIAL TRIAL, SIZE 5, 18 MM T72-2-0521 SCORPIO CR TIBIAL TRIAL, SIZE 5, 21 MM T72-2-0524 SCORPIO CR TIBIAL TRIAL, SIZE 5, 24 MM T72-2-0708 SCORPIO CR TIBIAL TRIAL, SIZE 7, 8 MM T72-2-0710 SCORPIO CR TIBIAL TRIAL, SIZE 7, 10 MM T72-2-0712 SCORPIO CR TIBIAL TRIAL, SIZE 7, 12 MM T72-2-0715 SCORPIO CR TIBIAL TRIAL, SIZE 7, 15 MM T72-2-0718 SCORPIO CR TIBIAL TRIAL, SIZE 7, 18 MM T72-2-0721 SCORPIO CR TIBIAL TRIAL, SIZE 7, 21 MM T72-2-0724 SCORPIO CR TIBIAL TRIAL, SIZE 7, 24 MM T72-2-0908 SCORPIO CR TIBIAL TRIAL, SIZE 9, 8 MM T72-2-0910 SCORPIO CR TIBIAL TRIAL, SIZE 9, 10 MM T72-2-0912 SCORPIO CR TIBIAL TRIAL, SIZE 9, 12 MM T72-2-0915 SCORPIO CR TIBIAL TRIAL, SIZE 9, 15 MM T72-2-0918 SCORPIO CR TIBIAL TRIAL, SIZE 9, 18 MM T72-2-0921 SCORPIO CR TIBIAL TRIAL, SIZE 9, 21 MM T72-2-0924 SCORPIO CR TIBIAL TRIAL, SIZE 9, 24 MM T72-2-1108 SCORPIO CR TIBIAL TRIAL, SIZE 11, 8 MM T72-2-1110 SCORPIO CR TIBIAL TRIAL, SIZE 11, 10 MM T72-2-1112 SCORPIO CR TIBIAL TRIAL, SIZE 11, 12 MM T72-2-1115 SCORPIO CR TIBIAL TRIAL, SIZE 11, 15 MM T72-2-1118 SCORPIO CR TIBIAL TRIAL, SIZE 11, 18 MM T72-2-1121 SCORPIO CR TIBIAL TRIAL, SIZE 11, 21 MM T72-2-1124 SCORPIO CR TIBIAL TRIAL, SIZE 11, 24 MM All lots.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA including OH, TX, MS, and CO and the countries of Australia, Hong Kong, Taiwan, India, Korea, Japan, Chile, Brazil, Columbia, Venezuela, , Panama, Santo Domingo, Mexico, Argentina, Costa Rica, Guatemala, Peru,Sweden, Germany, Netherlands, France, Spain, Italy, Romania, South Africa, United Kingdom. and Canada.
  • Descripción del producto
    SCORPIO CR TIBIAL TRIAL, non sterile, made in the USA || Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. || The Tibial trial are utilized during surgery to assess the overall component fit, ligament stability, and joint range of motion prior to final implantation of the insert to the tray.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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