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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00830-3
Product Name/Description Xia 3 Torque Wrench and Mantis Redux Torque Wrench (Supplied as part of Xia 3 instrument tray)

Xia 3 Torque Wrench
Catalogue Number: 48237028
Lot Number: 093655

Mantis Redux Torque Wrench
Catalogue Number: 48287028
Lot Number: 098400

(Supplied as part of Xia 3 instrument tray)

ARTG number: 160151

Instrument Tray Number: 48230012-T, 48230004-T, 48289001-T
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 16/08/2012
Responsible Entity Stryker Australia Pty Ltd
Reason/Issue Stryker Spine has become aware that instruments of the affected lot may fracture at the hex tip of the torque wrench during final tightening.
Recall Action Recall
Recall Action Instructions Review the Xia 3 instrument trays for the affected wrenches. All affected wrenches must be removed and quarantined until collected or returned.
Contact Information 02 9467 1111 - Stryker Regulatory Affairs