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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01315-1
Product Name/Description	Total Hip Software Application 3.1 & 3.1.1 for use with 3.0 Mako system (Robotic surgical navigation system used during total hip arthroplasty) Item Numbers: 212212-01, 212212-03, 212212-99, 212212, 212103-01, 212103-03, 212103-99, 212103, 212110, 212100-01, 212100-03, 212100, 212220-01, 212220-03, 212220, 212042, 212034, 212239, 212240, 212243, 212244 (Kits that include software) ARTG Number: 223106
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	13/10/2016
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker has identified an issue with the THA 3.1 and THA 3.1.1 software which may cause the surgeon to experience a feeling of vibration in the robotic arm during acetabular preparation. Should vibration occur, the surgeon may need to reposition the arm during reaming of a planned cup position which may result in complications associated with extended surgery time of less than 15 minutes. The occurrence of this vibration will be corrected through the installation of an upgraded software version THA 3.1.1.1 on the Mako system.
Recall Action	Recall for Product Correction
Recall Action Instructions	Stryker is advising users to inspect inventory for affected products. Users with affected product will be contacted by Stryker who will coordinate the installation of a software update as a permanent correction. In the interim, users can continue to use the affected product and mitigate the risk of vibration by following the instructions on the User Guide (PN 210555 – THA 3.1 Application User Guide, PN 212026 – THA 3.1.1 Application User Guide) and Surgical Technique (PN 210558 – THA 3.1 Surgical Technique, PN 212027 – THA 3.1.1 Surgical Technique) for proper pin placement/ securement, recommended Mako system setup and patient securement. This action has been closed-out on 18/05/2017.
Contact Information	02 9467 1175 - Stryker Recalls Specialist