Product Wiki · Recalls · Health Canada — Medical Devices

ProFile Vortex Blue (2018-09-24) — recall 58257

Health Canada — Medical Devices · Canada · 2018-10-19 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
58257
Date of alert
2018-10-19
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The size 40/.04 21 MM file in the assortment pack contained an incorrect blade in the 40/.04 handle: actual blade was a Vortex Blue 15:.06 21 MM. The 15/.06 tile blade is smaller and can potentially prevent the physical cleaning of the apical dentinal area. This could potentially result in the need to spend additional unplanned time and instruments with a larger diameter to complete the procedure.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/profile-vortex-blue-2018-09-24

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