Events

Retiro De Equipo (Recall) de Device Recall TORQ Sternal Closure Device

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 Kardium.

¿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
    63111
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0054-2013
  • Fecha de inicio del evento
    2012-08-28
  • Fecha de publicación del evento
    2012-10-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112575
  • 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
    Twister, wire - Product Code HXS
  • Causa
    The torq sternal closure device, lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use.
  • Acción
    Kardium Inc. sent an "URGENT: TORQ STERNAL CLOSURE DEVICE RECALL" e-mailed dated August 30, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the TORQ Sternal Closure Device lot 062711 immediately. Contact the firm at 604-248-8891, x285 for any questions about this recall.

Device

Device Recall TORQ Sternal Closure Device
  • Modelo / Serial
    Lot No. 062711. Expiry date is June 2014.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution-including the states of FL, GA, IL, and NH.
  • Descripción del producto
    TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. || The Catalog numbers are: || 17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and, || 15-00001 (or 17-00002): TORQ Sternal Closure Device 10-pack - Sterile. || The device is supplied double-pouched, inside a shelf box containing 10 devices each. Shelf boxes are shipped to customers in either a small shipping carton containing one (1) shelf box (for a total of 10 devices), or large shipping carton containing six (6) shelf boxes (for a total of 6 x 10 = 60 devices). || This product is used to close the sternal wires during cardiac surgery, and it is not an implantable device. The TORQ Sternal Closure device is used during sternal closure to tension and twist standard stainless steel surgical sutures of USP size 6 or 7 (metric size 8.0 or 9.0). The TORQ device is designed for use as a standard surgical suture wire twister for sternal closure. (Surgical sutures are not provided with the device.) The TORQ device is disposable, single-use, non-implantable and supplied sterile.
  • Manufacturer
    Kardium

Manufacturer

Kardium
  • Dirección del fabricante
    Kardium, 12851 Rowan Pl, Richmond Canada British Columbia
  • Empresa matriz del fabricante (2017)
    Kardium Inc
  • Source
    USFDA