Product Wiki · Recalls · Health Canada — Medical Devices

Low Profile Rotate with EVO (prosthetic device) (2015-03-04) — recall 53455

Health Canada — Medical Devices · Canada · 2015-04-27 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
53455
Date of alert
2015-04-27
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: The threads of the outer tube of the shock module of low profile rotate are short, which results in insecure assembly. Use of the product may cause the patient to fall with continued use, as the shock module can become loose from the foot blade.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/low-profile-rotate-evo-prosthe

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