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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00910-1
Product Name/Description	Triathlon Modular Handle (a reusable surgical instrument used in total and partial knee replacements) Item Number: 6541-4-808 All Lot Numbers ARTG Number: 140892
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	8/07/2016
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker has received complaints from customers about the device dissociating or breaking during use. An analysis indicated that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved by the supplier, potentially resulting in disassociation from the instrument. There is a risk that the handle components, including a dowel pin and a locking pin, may potentially disassociate and fall into the wound intraoperatively, necessitating retrieval. There have been no injuries reported as a result of this issue.
Recall Action	Recall
Recall Action Instructions	Stryker is advising users to inspect inventory and remove the affected devices from the procedure trays. The trays can continue to be used once the affected items have been removed. The affected devices can be returned to Stryker. This action has been closed-out on 23/03/2018.
Contact Information	02 9467 1175 - Stryker