OFFICIAL-SOURCE RECALL · AUSTRALIA
Orthopaedic implant components manufactured from ultra-high Recall: Classification Class II Reason for the
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
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- Brand
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- Product
- Orthopaedic implant components manufactured from ultra-high molecular weight polyethylene (UHMWPE)
- Manufacturer
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- Lot number
- numbers, Numbers
- Batch number
- numbers
- Date code
- dates
- Expiration date
- dates
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
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
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
Official recall notice
Orthopaedic implant components manufactured from ultra-high molecular weight polyethylene (UHMWPE)
Agency: Therapeutic Goods Administration
Official publication date: August 11, 2026
Read the official AU_TGA_DRAC recall notice →Scan products you own
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