Health Canada Medical Device Recall

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Recalls - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/recalls.html

Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report [2020-12-11] Product Recall Procedures Health Products and Food Branch Inspectorate - Recall Policy (POL-0016)

Guide to Recall of Medical Devices (GUI-0054) - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/medical-devices-recall-guide-0054.html

Use the Medical Device Recall Reporting Form - Initial (FRM-0360) to complete your initial recall report. Submit a section 65 final report to your nearest Health …

Advisories, Warnings and Recalls – Drugs and health …

https://www.canada.ca/en/health-canada/services/drugs-health-products/advisories-warnings-recalls.html

To this end, the Department posts safety alerts, public health advisories, press releases and other notices related to therapeutic health products from industry to health professionals, …

Adverse reactions, medical device incidents and health …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/adverse-reactions-incidents-recalls-2019-summary.html

Medical Device Incidents - Drug and Health Product Register

https://hpr-rps.hres.ca/mdi_landing.php

Search Medical Device Incidents. Search for term (s) Download Full Extract. Disclaimer. Date modified: 2021-07-14.

Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html

The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis …

Compliance and enforcement of medical devices

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices.html

Recall reporting for medical devices. Medical device initial recall reporting form (FRM-0360)[2016-11-03] Medical device final recall reporting form (FRM-0360)[2016 …

Find recalls, advisories and safety alerts - Canada.ca

https://recalls-rappels.canada.ca/en

Latest recalls and safety alerts. Health Canada warns that Dr. Crafty branded epoxy kits may pose an injury hazard due to improper labelling. Alert Consumer product advisory | …

Medical Device Recall Reporting Form - Initial

https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/compli-conform/prob-report-rapport/frm_0360_medical_device_initial_recall_reporting-eng.pdf

To capture the information manufacturers and importers are required to report to Health Canada on or before undertaking a recall, as per S. 64 of the Medical Devices …

Transport Strut Hoffmann Lrf - Canada.ca

https://recalls-rappels.canada.ca/en/alert-recall/transport-strut-hoffmann-lrf

Issue. Stryker has identified a nonconformance in specific lots of Hoffmann Lrf bone transport struts. Specifically, the thread pitch is oversized at the distal end of the …

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