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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00038-1
Product Name/Description	Xia 3 Titanium Torque Wrench, Mantis Redux Torque Wrench & Xia Torque Wrench (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 Number: 48237028 Lot Numbers: 11E045, 11E046 Mantis Redux Torque Wrench Catalogue Number: 48287028 Lot Numbers: 127051, 098525 Xia Torque Wrench Catalogue Number: 03807028 Lot Numbers: 092793, 11E039, 123746 ARTG Number: 160151
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	21/01/2014
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker has received reports that the hex tip of the affected Torque Wrenches of an identified Lot Number subset have been fracturing during final tightening. The hex tip of the wrench has broken off and separated from the main tube. This is a follow up action to a previous recall (TGA Ref: RC-2013-RN-01017-3)
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 affected products. Unaffected replacement units will be provided.
Contact Information	02 9467 1214 - Stryker Regulatory Affairs & Quality Assurance