Events

Recall of Device Recall TORQ Sternal Closure Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kardium.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63111
  • Event Risk Class
    Class 2
  • Event Number
    Z-0054-2013
  • Event Initiated Date
    2012-08-28
  • Event Date Posted
    2012-10-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112575
  • Notes / Alerts
    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.
  • Extra notes in the data
    Twister, wire - Product Code HXS
  • Reason
    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
  • Model / Serial
    Lot No. 062711. Expiry date is June 2014.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-including the states of FL, GA, IL, and NH.
  • Product Description
    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
  • Manufacturer Address
    Kardium, 12851 Rowan Pl, Richmond Canada British Columbia
  • Manufacturer Parent Company (2017)
    Kardium Inc
  • Source
    USFDA