Device Recall TORQ Sternal Closure Device

  • Modèle / numéro de série
    Product Code: TQ01A.  Lot #: 20100127 (expiration 2011-01); Lot #: 20100223 (expiration 2011-02).
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and Canada.
  • Description du dispositif
    TORQ Sternal Closure Device, SINGLE-USE || Intended use: The device is a sterile, single-use only surgical instrument used to tension and twist USP size 5, 6, and 7 (metric size 7.0, 8.0, and 9.0) stainless steel surgical sutures for sternal closure. The device should not be used on patients with poor sternal bone quality.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    KARDIUM INC., 100 - 12851 ROWAN PL., RICHMOND Canada British Columbia
  • Société-mère du fabricant (2017)
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    Lot No. 062711. Expiry date is June 2014.
  • Classification du dispositif
  • 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