Z-2259-2013 Class II Terminated
FDA device recall Z-2259-2013 was initiated by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical on September 13, 2013 and is designated Class II. 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 … The recall status is terminated (terminated February 11, 2014). Affected quantity: 197 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2013
- Initiation Date
- September 13, 2013
- Termination Date
- February 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 197 units
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.
Distribution Pattern
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.
Code Information
Part Number 33660. Syringe Lot Number 4580333. Autobag Lot Number 4584609.