Health Canada — Medical Devices · Canada · 2016-09-06 · Type II
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Reported risk: The affected devices were manufactured with an out of specification retainer groove location. In the event the failure occurs, it would be obvious to the user in that the devices would not provide an audible indicator that the poly lock has engaged. In the event the construct is tight, the user should notice the limited range of motion. However, in the worst case situation, if the device gives a false indicator of locking, the user would not recognize the failure.
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