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Type of Product	Medical Device
TGA Recall Reference	RC-2018-RN-00725-1
Product Name/Description	Mako RIO System Irrigation Clip (partial knee application only) Catalogue Number: 111690 Lot Numbers: 176364, 178346, 181337, 185213, 186561, 189709, 190559, 193643 and 195763A1 ARTG Number: 223929 (Stryker Australia Pty Ltd - Irrigation tubing set, general purpose)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	19/06/2018
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker has discovered that specific lots of the Mako RIO System Irrigation Clip have the potential to fracture. The RIO System Irrigation Clip is a sterile disposable, used to direct saline flow for the burring tool during a Mako Partial Knee surgery. In the event of a break in the Mako RIO System Irrigation Clip, potential hazards of a fractured device and/or foreign object (inert particulate left in wound) may occur.
Recall Action	Recall
Recall Action Instructions	Stryker is advising customers to inspect inventory and quarantine affected product, Stryker will contact customers to arrange return of affected product. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	02 9467 1175 - Stryker