Events

Retiro De Equipo (Recall) de Device Recall Global Modular Replacement System (GMRS) Extension Piece 60 mm

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
    50095
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2624-2010
  • Fecha de inicio del evento
    2005-05-05
  • Fecha de publicación del evento
    2010-09-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74715
  • 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, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
  • Causa
    Mislabeled package: package labeled as gmrs extension piece 60 mm, lot zycoc1 actually contains a gmrs extension piece 70 mm extension piece.
  • Acción
    Stryker issued Important Market WIthdrawal letters dated May 5, 2005 to customers and distributors. The letters identified the affected product, the labeling issue, and actions to be taken by the customer or distributor. Customers were instructed to identify and quarantine affected product, which will be reconciled and returned by the Stryker sales representative. Distributors were instructed to identify affected product, reconcile all product on an attached Product Accountability Form to be faxed to Stryker at 201 831-4825 within two days of receipt of the letter. The affected product was to be returned using the enclosed pre-paid mailing label. Contact the Stryker sales representative to re-order product that is being returned. Stryker can be contacted at 201 831-5825.

Device

Device Recall Global Modular Replacement System (GMRS) Extension Piece 60 mm
  • Modelo / Serial
    Catalog number: 6495-6-060; Lot code LZYOC1
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution: USA, including the states of AZ, FL, MD, and PA.G
  • Descripción del producto
    GMRS Extension Piece, 60 mm; Sterile || Stryker Howmedica Osteonics; Howmedica Internation S. de. R.L. Limerick, Ireland. || The Global Modular Replacement System is intended to be used with the components of the Howmedica Osteonics Modular Replacement System , the Howmedica Osteonics Modular Rotating Hinge Knee System and/or the Howmedica Osteonics Kinematic Rotating Hinge Knee System in situations where replacement of extensive bone loss in the femur and/or proximal tibia is required. The Proximal Femoral Module and Distal Femoral Module of the GMR may be used together, or with the components of the MRS, in replacement of the total femur.
  • 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