Recall Z-0054-2013 ยท HXS Twister, Wire
Kardium
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 e
| Date | Oct 11, 2012 (initiated Aug 28, 2012) |
| Status | Terminated |
| Reason | The TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use. |
| Root cause | Employee error |
| Action | Kardium Inc. sent an "URGENT: TORQ STERNAL CLOSURE DEVICE RECALL" e-mailed dated August 30, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the TORQ Sternal Closure Device lot 062711 immediately. Contact the firm at 604-248-8891, x285 for any questions about this recall. |
| Quantity | 480 units |
| Distribution | Nationwide Distribution-including the states of FL, GA, IL, and NH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.