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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Event Detail

Event ID 66276
Product Type Devices
Status Ongoing
Recalling Firm Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
City Orange
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-13
Initial Firm Notification of
Consignee or Public
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
NX3 Try-In Gel. The product is used as a tooth shade resin material. Part Number 33660. Syringe Lot Number 4580333. Autobag Lot Number 4584609. Class II 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. 197 units Z-2259-2013