Product Wiki · Recalls · Health Canada — Medical Devices

Scorpio and Duracon Total Knee Systems — recall 74779

Health Canada — Medical Devices · Canada · 2023-12-21 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
74779
Date of alert
2023-12-21
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Orthopaedics
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/scorpio-and-duracon-total-knee

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