Events

Retiro De Equipo (Recall) de Device Recall Triathlon PKR Peg Drill

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
    57857
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1835-2011
  • Fecha de inicio del evento
    2011-02-09
  • Fecha de publicación del evento
    2011-03-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-11-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97590
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
  • Causa
    Stryker orthopaedics has identified a trend of complaints involving reports of the peg drill cold welding to the drill guide, causing the peg drill to cease functioning. if cold welding of these components occurs, the following potential patient and/or surgeon or surgical staff harms may results.
  • Acción
    Stryker sent Urgent Product Recall letters on February 9, 2011, and February 10, 2011, via Fed Ex. to all affected customers. The letters identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete and fax back the attached Product Recall Acknowledgement Form as soon as possible to 201-831-6069. For questions regarding this recall call 201-972-2100.

Device

Device Recall Triathlon PKR Peg Drill
  • Modelo / Serial
    Catalog Number 5650-4-512 Catalog Number 5650-4-536
  • Clasificación del producto
    Orthopedic Devices
  • Distribución
    Worldwide Distribution - USA , Sweden, Germany; France, Portugal, UK, Canada, Australia, and New Zealand,
  • Descripción del producto
    Triathlon PKR Peg Drill, Catalog Number: 5650-4-512 (Size 1-2 Peg Drill); Catalog Number: 5650-4-536 (Size 3-6 Peg Drill); || Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 || The Triathlon-PKR Knee System is indicated for primary partial knee resurfacing (PKR). This system utilizes two fixation pegs on the femoral component for fixation and alignment. To prepare for these features, a peg drill, drill guide, and drill through femoral trial are provided. The femoral Trial Drill Guide is attached to the Modular Handle and assembled into the holes on the articulation surface of the Femoral Trial. Using the appropriately sized Peg Drill (Small Drill for sizes 1-2, Large Drill for sizes 3-6), both holes are drilled. The Peg drill is advanced until the step on the drill makes contact with the front face of the Femoral Trial Drill Guide.
  • 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