Health Canada — Medical Devices · Canada · 2016-01-22 · Type II
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Reported risk: Corflex received notification from a material supplier that a component used to manufacture the brace was out of specification. The hardness of the drop lock teeth could be insufficient, causing this feature to fail under stress. In circumstances where a sudden and/or higher than normal force is exerted against an engaged drop lock, the brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint, posing a safety risk to the patient.
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