Z-1973-2010

TORQ Sternal Closure Device, SINGLE-USE

Name: Z-1973-2010 TORQ Sternal Closure Device, SINGLE-USE
Creator: Kardium Inc.
Published: 2010-03-31
License: https://open.fda.gov/license/

KARDIUM Inc. / initiated 2010-03-31 / Terminated

FDA source

KARDIUM INC. began a recall of 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... on 2010-03-31. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1973-2010
Status: Terminated
Initiated: 2010-03-31
Posted: 2010-07-09
Terminated: 2010-10-07
Recalling firm: KARDIUM Inc.
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.
Product code: HXS Twister, Wire
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 root cause: 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.
Product codes and lots: Product Code: TQ01A. Lot #: 20100127 (expiration 2011-01); Lot #: 20100223 (expiration 2011-02).

Product code HXS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)