Health Canada — Medical Devices · Canada · 2013-10-25 · Type II
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Reported risk: The NX3 Try-In gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled. There is a risk that use of the affected material to evaluate shade prior to cementation may result in an unanticipated final restoration color requiring the need to remove and repeat the restoration.
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