Health Canada — Medical Devices · Canada · 2018-01-12 · Type II
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Reported risk: The extender that is packaged with the Swish Tapered and SwishPlus Implant may have been packaged in the incorrect position (upside down in the plastic retainer). This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible inflammation of the soft tissue to the patient. This, in turn, may result in minor medical intervention by the Clinician.
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