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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Event Detail

Event ID 63111
Product Type Devices
Status Ongoing
Recalling Firm Kardium
City Richmond
State BC
Country CA
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-28
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution-including the states of FL, GA, IL, and NH.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers are: 17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and, 15-00001 (or 17-00002): TORQ Sternal Closure Device 10-pack - Sterile. The device is supplied double-pouched, inside a shelf box containing 10 devices each. Shelf boxes are shipped to customers in either a small shipping carton containing one (1) shelf box (for a total of 10 devices), or large shipping carton containing six (6) shelf boxes (for a total of 6 x 10 = 60 devices). This product is used to close the sternal wires during cardiac surgery, and it is not an implantable device. The TORQ Sternal Closure device is used during sternal closure to tension and twist standard stainless steel surgical sutures of USP size 6 or 7 (metric size 8.0 or 9.0). The TORQ device is designed for use as a standard surgical suture wire twister for sternal closure. (Surgical sutures are not provided with the device.) The TORQ device is disposable, single-use, non-implantable and supplied sterile. Lot No. 062711. Expiry date is June 2014. Class II The TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use. 480 units Z-0054-2013