Reported Sep 25, 2013 · Terminated
NX3 Try-In Gel. The product is used as a tooth shade resin material.
Kerr/Pentron, dba Kerr Corporation and Pentron Clinical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical · 1717 W Collins Ave · Orange, CA · 92867-5422
Is this the product you have?
- NX3 Try-In Gel. The product is used as a tooth shade resin material.
- Lot codes and dates
- Part Number 33660. Syringe Lot Number 4580333. Autobag Lot Number 4584609.
- Amount recalled
- 197 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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