Events

Rappel de Device Recall TORQ Sternal Closure Device

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Kardium.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    63111
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0054-2013
  • Date de mise en oeuvre de l'événement
    2012-08-28
  • Date de publication de l'événement
    2012-10-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112575
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Twister, wire - Product Code HXS
  • Cause
    The torq sternal closure device, lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use.
  • Action
    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
  • Modèle / numéro de série
    Lot No. 062711. Expiry date is June 2014.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution-including the states of FL, GA, IL, and NH.
  • Description du dispositif
    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
  • Adresse du fabricant
    Kardium, 12851 Rowan Pl, Richmond Canada British Columbia
  • Société-mère du fabricant (2017)
    Kardium Inc
  • Source
    USFDA