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 Depuy (Ireland) Attune System - Tibial Insert Fixed Bearing Posterior Stabilized [Model or Catalogue Number: 1516-40-507; Lot or Serial Number: JN6613] [HKMD No.: 120421].
According to Health Canada, the subject lot was sent for sterilization twice, this exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the tibial insert material properties.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/attune-system-tibial-insert-fixed-bearing-posterior-stabilized
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 09 Mar 2023