NX3 Try-In Gel. The product is used as a tooth shade recall
NX3 Try-In Gel. The product is used as a tooth shade resin material.
Why was NX3 Try-In Gel. The product is used as a tooth shade 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number 33660. Syringe Lot Number 4580333. Autobag Lot Number 4584609.
- Product
- NX3 Try-In Gel. The product is used as a tooth shade resin material.
- Recalling firm
- Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
- Quantity
- 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.
- Recall date
- September 25, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)