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
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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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