Product Wiki · Recalls · Health Canada — Medical Devices

Profile Vortex rotary files (2016-07-07) — recall 55581

Health Canada — Medical Devices · Canada · 2016-07-29 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
55581
Date of alert
2016-07-29
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: As per health hazard evaluation (HHE-309) the risk is level III as the health consequence is such that it requires, or has the potential to require medical or surgical intervention. There is no long-term health impact on the patient. Also, additional/unplanned interventions or corrections during the course of a treatment or after a treatment with no health risk to the patient could be experienced. The use of a larger dimension instrument can adversely affect the ability to complete endodontic treatments.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/profile-vortex-rotary-files-20

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