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Health Canada Medical devices

Scorpio and Duracon Total Knee Systems

Issued December 21, 2023
Issue
The industry guidance for storage duration of Ultra High Molecular Weight Polyethylene (UHMWPE) raw material used in the manufacture of soft implant bearing/articulating material of prosthetic joints is less than 5 years. Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. Stryker has become aware that the devices listed in the product/lot number attachment PFA 3306872 section of the customer letter have been manufactured with UHMWPE raw material aged over 5 years. Recall Start Date: December 5, 2023
Hazard description
Performance
Product
Product name
Scorpio and Duracon Total Knee Systems
Reference
ID
RA-74779