Product Wiki · Recalls · Health Canada — Medical Devices

Precice System — recall 63804

Health Canada — Medical Devices · Canada · 2022-01-10 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
63804
Date of alert
2022-01-10
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Orthopaedics
Product type
Medical devices
Reported risk: NSO is notifying that the products outlined are not indicated for use in individuals under the age of 18 years old. Also, NSO intends to make users aware of the gaps in the biological assessments for these devices as outlined in ISO 10993-1:2018 biological evaluation of medical device. Recall start date: Feb 1, 2021
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/precice-system

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