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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01017-1
Product Name/Description	Xia 3 Titanium Torque Wrench & Xia 3 Titanium Torque Wrench Short (used for final tightening of the blocker on the head of the pedicle screw during posterior spinal fusion surgery) Xia 3 Titanium Torque Wrench Catalogue #: 48237028 (48230012-T, 48230004-T, 48230012NSW-T, 48230004NZ-T, WKSHP48230004-T) Lot Numbers: 11E042, 11E047 Xia 3 Titanium Torque Wrench Short Catalogue #: 482397028 (HANXIA3-T, HUNTSPINEEXT-T, 482370-T) Lot Numbers: 11E036, R11E036, 11A957 ARTG Number: 160151
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	1/10/2013
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker Spine has received reports that the hex tip of the Xia 3 Torque Wrenches of an identified Lot Number subset have been fracturing during final tightening. The hex tip of the wrench is broken off and separated from the main tube.
Recall Action	Recall
Recall Action Instructions	Customers are requested to quarantine all affected lots. A Stryker representative will contact all affected customers to arrange for collection of the Xia 3 Torque Wrench. Unaffected replacement units will be provided.
Contact Information	02 9467 1214 - Stryker Regulatory Affairs and Quailty Assurance Office