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Recall Observatory FDA recall evidence

Device product

NX3 Try-In Gel. The product is used as a tooth shade resin material.

Z-2259-2013

September 13, 2013

Class II

Product summary

Firm
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Event
Event 66276
Status
Terminated
Classification
Class II
Quantity
197 units
Official record key
device-enforcement:Z-2259-2013

Official wording

Reason: Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of 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.

Code information: Part Number 33660. Syringe Lot Number 4580333. Autobag Lot Number 4584609.

Distribution pattern: Worldwide Distribution, including Nationwide in the US and the countries of Canada, Great Britain, Australia, France, Germany, Italy, Denmark, Hong Kong, China, Brazil and Saudi Arabia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of 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.