Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning Howmedica Osteonics Corporation Scorpio and Duracon Total Knee Systems [HKMD No.:150359].
According to Health Canada, 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. The manufacturer has become aware that some devices have been manufactured with UHMWPE raw material aged over 5 years.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/scorpio-and-duracon-total-knee-systems
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 Dec 2023