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Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical recalls NX3 Try-In Gel. The product is used as a tooth shade resin material.
Recalled September 25, 2013 · FDA recall Z-2259-2013 · Kerr/Pentron,
Hazard
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. · FDA Class II
Units
197 units
Sold at
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.
Description
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.
Product
NX3 Try-In Gel. The product is used as a tooth shade resin material.
Manufacturer(s)
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →