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 INC..

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
    55419
  • Event Risk Class
    Class 2
  • Event Number
    Z-1973-2010
  • Event Initiated Date
    2010-03-31
  • Event Date Posted
    2010-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90805
  • 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
    A component of the device is installed incorrectly which can result in the component falling out of the device and into the patient during use.
  • Action
    The firm, Kardium, informed it's US distributor on March 30, 2010 by e-mail. The distributor was instructed to return all unused product to Kardium. The units remaining at hospitals will be returned to Kardium by the distributor sale reps. If you have any questions, please contact (604) 248-8891.

Device

Device Recall TORQ Sternal Closure Device
  • Model / Serial
    Product Code: TQ01A.  Lot #: 20100127 (expiration 2011-01); Lot #: 20100223 (expiration 2011-02).
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and Canada.
  • Product Description
    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
    KARDIUM INC.

Manufacturer

KARDIUM INC.
  • Manufacturer Address
    KARDIUM INC., 100 - 12851 ROWAN PL., RICHMOND Canada British Columbia
  • Manufacturer Parent Company (2017)
    Kardium Inc
  • Source
    USFDA