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Terminated

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.

FDA Recall Z-1973-2010 · Posted 2010-07-09

Recalling FirmKARDIUM INC.
Recall StatusTerminated
Product CodeHXS
Date Initiated2010-03-31
Date Terminated2010-10-07
Product Quantity420 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide distribution: USA and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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