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U.S. Department of Health and Human Services

Class 2 Device Recall TORQ Sternal Closure Device

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  Class 2 Device Recall TORQ Sternal Closure Device see related information
Date Initiated by Firm March 31, 2010
Date Posted July 09, 2010
Recall Status1 Terminated 3 on October 07, 2010
Recall Number Z-1973-2010
Recall Event ID 55419
Product Classification Twister, wire - Product Code HXS
Product 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.
Code Information Product Code: TQ01A.  Lot #: 20100127 (expiration 2011-01); Lot #: 20100223 (expiration 2011-02).
Recalling Firm/
Manufacturer		 KARDIUM INC.
100 - 12851 ROWAN PL.
RICHMOND Canada British Columbia
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 420 units
Distribution Worldwide distribution: USA and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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