NX3 Try-In Gel. The product is used as a tooth shade resin material.
Reported: September 25, 2013 Initiated: September 13, 2013 #Z-2259-2013
Product Description
NX3 Try-In Gel. The product is used as a tooth shade resin material.
Reason for Recall
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.
Details
- Recalling Firm
- Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
- Units Affected
- 197 units
- Distribution
- 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.
- Location
- Orange, CA
Frequently Asked Questions
What product was recalled? ▼
NX3 Try-In Gel. The product is used as a tooth shade resin material.. Recalled by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical. Units affected: 197 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 25, 2013. Severity: Moderate. Recall number: Z-2259-2013.
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