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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 Devicesee related information
Date Initiated by FirmMarch 31, 2010
Date PostedJuly 09, 2010
Recall Status1 Terminated 3 on October 07, 2010
Recall NumberZ-1973-2010
Recall Event ID 55419
Product Classification Twister, wire - Product Code HXS
ProductTORQ 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).
FEI Number 3007603855
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
ActionThe 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 Commerce420 units
DistributionWorldwide distribution: USA and Canada.
Total Product Life CycleTPLC 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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