| 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 |
|
| 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 |