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Type of Product	Medical Device
TGA Recall Reference	RC-2018-RN-00280-1
Product Name/Description	Mako Onlay Insert Extractor (part of the Restoris MCK (Multi Compartmental Knee) Unicondylar System) Item Number: 160430 Lot Numbers: 19020414, 19090616, 19090915, 19100616, 19100915, 19110317, 19110616, 19110915, 19130315, 19140315, 19451016,19471016, 19490515, 19500515, 19510515, 19520515, 19530515, 26051212, 26070512, 26080913, 26130512, 26170513, 26201111, 26290412, 26440912 ARTG Number: 223107 (Stryker Australia Pty Ltd - Surgical procedure kit, orthopaedic, reusable)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	3/04/2018
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker has received a report that a hinge pin disassociated from the Mako Onlay Insert Extractor. In that reported case, the disassociated hinge pin was discovered prior to the device being used in surgery and a backup device was available and subsequently used to complete the procedure. In the event of an undetected disassociated hinge pin, the potential hazards include the hinge pin being left in the wound or excessive metal wear giving rise to debris. To date, there have been no injuries reported as a result of this issue.
Recall Action	Recall
Recall Action Instructions	Stryker is advising users to inspect stock and return any remaining units of the affected lot numbers. This action has been closed out on the 16/10/2018.
Contact Information	02 9467 1175 - Stryker