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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00100-1
Product Name/Description Mako RIO System Ethernet to Fiber Optic Converter

Item Number: 200933

All Lot Numbers

ARTG Number: 223105
(Stryker Australia Pty Ltd - Robot, surgical, navigation unit)
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 5/02/2018
Responsible Entity Stryker Australia Pty Ltd
Reason/Issue Stryker has discovered that certain Ethernet to Fibre Optic Converters did not pass testing due to a RIO Connection error. A RIO Connection error will occur when communication is lost between the RIO and the Guidance Module. In the event a Mako System experiences a RIO Connection error, a network connection error message will appear on the system display
Recall Action Product Defect Correction
Recall Action Instructions Stryker will arrange replacement of all Ethernet to Fibre Optic Converters of affected units with updated converters.

This action has been closed out on the 08/11/2018.
Contact Information 02 9467 1175 - Customer Service Support