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TGA Action ID	RC-2026-RN-00611-1
Type of Product	Medical Device
Product Name/Description	Orthopaedic implant components manufactured from ultra-high molecular weight polyethylene (UHMWPE) Catalogue Numbers: 692244, 692248, 6900022E, 6900028G, UH13822, UH14022, UH14122, UH14126, UH14222, UH14322, UH14326, UH14428, UH14726, UH14828 Lot Numbers: RE4EK0, RP673W, KP576W, 6D8274, 49510K, 7E5X23, 746AV4, 7V8J0V, E788E6, KL1YTE, PL4L5M, X82M1D, L16J85, L93PY2, 516JLV, RT8N8H, 2V6D0R, 7N7WX1, YX8NTJ, 5R3H24, 7307MN, PN3K4T, V95MVD, XD724J, 9M6KHT
ARTG Number	225310, 235283, 247373
Action Type	Recall / Product Alert
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Certain orthopaedic implants were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five (5) years. Industry guidance for storage duration of UHMWPE raw material used in the manufacture of implant bearing/articulating material of prosthetic joints is less than five (5) years. Product manufactured using UHMWPE raw material beyond the recommended storage duration has the potential for elevated levels of oxidation. Oxidation of UHMWPE material can impact material properties, potentially resulting in increased wear.
Instructions for Customers/Users	Upon receipt of the Recall letter, the customer is to: 1. Immediately review the Customer Letter and If affected product is identified, immediately quarantine and discontinue use. 2. Return the Response Form to Stryker with the details of all affected product that is being returned. 3. If the customer has loaned, sold or disposed of any of the affected product, they must inform Stryker immediately A Stryker representative will help coordinate the return and replacement of any affected product. Upon receipt of the Product Alert letter, the customer (surgeon) is to: Immediately review the Customer Letter, noting Patients treated with an impacted product should continue to be followed per the normal protocol established by their surgeon(s). There are no recommended changes to the frequency of the standard follow-up care protocol.
Action Commencement Date	11/08/2026
Responsible Entity	Stryker Australia Pty Ltd
Contact Information	0437 112 648 Avalon Grygorcewicz, Stryker Australia