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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00140-1
Product Name/Description	Triathlon Distal Capture Assembly Catalogue Number: 65411723 All lots Instrument trays that contain the affected device: 65418002-T & SHAPECONV-T ARTG number: 140892
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	24/02/2015
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker Orthopaedics has received complaints regarding the disassociation of the cross pin from the action triggers of the Triathlon Distal Capture Assembly, which could lead to a loose or disassociated action trigger mechanism and/or loose or disassociated cross pin. Although using a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty is optional, if the surgeon elects to utilize a capture and such disassociation occurs, there exists the potential for the following harms: ·Complications associated with a delay in surgery of =15 minutes; ·Revision surgery to retrieve loose component(s); ·Local Inflammatory response; ·Inflammatory response Stryker representatives will contact customers to physically inspect and remove affected units in the field.
Recall Action	Recall for Product Correction
Recall Action Instructions	A Stryker representative will arrange for all non-conforming components to be removed and a replacement arranged as required. In the event a Stryker Representative is not available to visit your location to perform the inspection, detailed inspection instructions are provided via the Customer Letter. This action has been closed-out on 21/04/2017.
Contact Information	02 9467 1052 - Stryker Orthopaedics Marketing