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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