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TGA Action ID	RC-2026-RN-00296-1
Type of Product	Medical Device
Product Name/Description	Trekking Knee System All lots Cancelled ARTG's: 296040, 296025, 296024, 287520, 287519, 287518, 287517, 287516, 287515, 287514, 287513, 287512, 287511, 287510, 287509, 287508, 287507, 287506, 287505, 287504, 287503, 287502, 283167, 283166, 200859
ARTG Number
Action Type	Product Alert
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	The Trekking Knee System has been identified as having higher than anticipated revision rates by the AOANJRR. Data from the AOANJRR demonstrates a higher risk of revision surgery with the Trekking Knee System when - the patella is resurfaced - a posterior stabilised version is implanted or - a rotating bearing is used. As of March 2026, it is no longer available for implantation in Australia.
Instructions for Customers/Users	For health care professionals: · Monitor patients who have had an implanted device from the Trekking Total Knee system and manage appropriately. · Inform patients of the following advice. For patients: · If you have an implanted device from the Trekking Total Knee system, you may be at a higher risk of requiring revision surgery. · Please see your doctor if you have any of the following symptoms: any new or worsening pain or swelling, inability to bear weight, or weakness around your implanted device. · The TGA does not recommend removal of an implanted device from patients who do not have any symptoms.
Action Commencement Date	18/05/2026
Responsible Entity	Orthotech Pty Ltd
Contact Information	07 3262 5033 - Sam Scott-Young, Orthotech