Recall Z-1973-2010 ยท HXS Twister, Wire
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.
| Date | Jul 9, 2010 (initiated Mar 31, 2010) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.