Device product
NX3 Try-In Gel. The product is used as a tooth shade resin material.
Z-2259-2013
Product summary
- 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
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.