FDAFDA · Food and drugs·Recall number Z-2259-2013
NX3 Try-In Gel. The product is used as a tooth shade resin material.
Published September 25, 2013 · Recall initiated: September 13, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
- Distributor
- 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.
- Lot
- Part Number 33660. Syringe Lot Number 4580333. Autobag Lot Number 4584609.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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