FDA Medical Device Recalls (openFDA)
KARDIUM INC.: 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.
- Recall number
- Z-1973-2010
- 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.
- Status
- Terminated
- Initiated
- 2010-03-31
- Posted
- 2010-07-09
- Terminated
- 2010-10-07
- 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.
- 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
- 420 units
- Distribution
- Worldwide distribution: USA and Canada.
- Lot, serial or model codes
- Product Code: TQ01A. Lot #: 20100127 (expiration 2011-01); Lot #: 20100223 (expiration 2011-02).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HXS
- Firm FEI
- 3007603855
- Firm city
- Canada
- Firm state
- British Columbia
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28