Events

Retiro De Equipo (Recall) de SuperCable ScrewDriver, 3.5mm Hex

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 Kinamed Inc.

¿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
    58808
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2588-2011
  • Fecha de inicio del evento
    2010-08-18
  • Fecha de publicación del evento
    2011-06-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100337
  • 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
    Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
  • Causa
    The recall was initiated due to inadequate mechanical strength of these screwdrivers' hexagonal tip feature, causing it to strip during final tightening.
  • Acción
    The firm, Kinamed Inc., sent a recall letter dated August 18, 2010 to consignees/customers via FedEx. The letter described the product, problem and actions to be taken. The customers were instructed to Immediately examine their stock and return any Kinamed SuperCable Screwdriver, 3.5mm Hex bearing these lot numbers, along with the completed attached Effectiveness Check Form and shipment under RMA #74567 to the attention of: "Director of Quality Assurance" Kinamed, Inc. 820 Flynn Road Carnarillo, CA 93012-8701 Note: The Kinamed sales agent shipped and had the product replaced for the customers. If you have any questions, please contact (303)-681-2208, (805) 384-2748 or (800) 827-5775

Device

SuperCable ScrewDriver, 3.5mm Hex
  • Modelo / Serial
    Lot Numbers K12899 (2pcs) & K12985 (3pcs)
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA (nationwide) state of: CO and country of: Columbia.
  • Descripción del producto
    Kinamed SuperCable Grip and Plate System Driver, 3.5mm Hex, Catalog Number: 35-860-2060 || The driver is intended to be used in conjunction with compression and locking bone screws for fixation of long bone fractures when Kinamed Trochanteric Grips & Cable-Plates are used. || Subsequent || Product Codes: HWC, JDQ.
  • Manufacturer
    Kinamed Inc

Manufacturer

Kinamed Inc
  • Dirección del fabricante
    Kinamed Inc, 820 Flynn Rd, Camarillo CA 93012
  • Empresa matriz del fabricante (2017)
    Kinamed Inc.
  • Source
    USFDA