Enforcement Report - Week of October 17, 2012
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Product Detail
| Product Description | 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. |
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| Recall Number | Z-0054-2013 |
| Classification | Class II |
| Code Info | Lot No. 062711. Expiry date is June 2014. |
| Product Distributed Qty | 480 units |
| Reason For Recall | The TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use. |
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. |
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