Events

Retiro De Equipo (Recall) de Device Recall Stryker Orthopaedics Sterile Knee Instrument Disposable Patella Cutter

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
    53858
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0529-2010
  • Fecha de inicio del evento
    2009-11-11
  • Fecha de publicación del evento
    2009-12-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-08-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86691
  • 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
    Patella Cutter - Product Code HTS
  • Causa
    Disposable patella cutters - 30 mm (catalog number 8000-0030, lot v31257001) were packaged and labeled as 33 mm disposable patella cutters (catalog number 8000-0033, lot v31257001 and vice versa.
  • Acción
    An "Urgent Product Recall" letter dated November 11, 2009 was sent to all affected Stryker branches, hospital risk management, hospital Chief or Orthopaedics and surgeons by Federal Express. The letter described the issue, potential hazards and risk mitigation factors and requested that the Recall Acknowledgement form be completed and returned. The Recall Acknowledgement form has information regarding the return of affected product to the firm. Direct questions to Stryker Orthopaedics by calling 1-201-831-5832.

Device

Device Recall Stryker Orthopaedics Sterile Knee Instrument Disposable Patella Cutter
  • Modelo / Serial
    Catalog Number 8000-0033; Lot code V31257001.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution (MA, NJ, FL, TN, OR and NY).
  • Descripción del producto
    Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter; || Stainless Steel, Disposable; || Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 || 33 mm size, One single unit to a package. || Note: The 30 mm instruments were not distributed. || The patella cutters are components of the Xcelerate Instruments and are used with additional devices to remove bone from the patella in preparation for a replacement implant. The Xcelerate Patella Reaming Instruments provide a means to prepare for implantation of either the Duracon or Scorpio Total Knee Systems patellar implants.
  • 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