Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00745-1
Product Name/Description	Xia 3 Titanium Torque Wrench Catalogue Number: 48237028 Lot Numbers: 098525, Xia 3 Torque Wrench Short Catalogue Number: 482397028 Lot Numbers: 11E035 ARTG Number: 160151
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	17/08/2015
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker has received reports that the hex tip of the listed Torque Wrenches have been fracturing during final tightening. The hex tip of the wrench has broken off and separated from the main tube. The manufacturer has identified four possible hazardous situations: · Delay in surgery time (< 5 minutes) if an alternative torque wrench is needed · Debris of non-implantable grade material falling into the wound · Over/under-tightening of the blocker if an alternate instrument is not available · Accidental implanting of the hex tip.
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. This action has been closed-out 18/04/2017.
Contact Information	02 9467 1167 - RA & QA Co-ordinator