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U.S. Department of Health and Human Services

Class 2 Device Recall NX3 TryIn Gel

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 Class 2 Device Recall NX3 TryIn Gelsee related information
Date Initiated by FirmSeptember 13, 2013
Date PostedSeptember 19, 2013
Recall Status1 Terminated 3 on February 11, 2014
Recall NumberZ-2259-2013
Recall Event ID 66276
510(K)NumberK001899 
Product Classification Material, tooth shade, resin - Product Code EBF
ProductNX3 Try-In Gel. The product is used as a tooth shade resin material.
Code Information Part Number 33660. Syringe Lot Number 4580333. Autobag Lot Number 4584609.
FEI Number 2024312
Recalling Firm/
Manufacturer		 Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information Contact
714-516-7400
Manufacturer 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.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionKerr Corporation initiated the voluntary recall by sending out notifications on 09/13/2013 via USPS 1st class mail. The recall notification letter, titled "URGENT: MEDICAL DEVICE RECALL", informed customer of the recall's product description, reason for recall, potential risk, instructions to customers and contact information.
Quantity in Commerce197 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = EBF
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