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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 Recall
NX3 TryIn Gel
see related information
Date Posted September 19, 2013
Recall Status1 Terminated on February 11, 2014
Recall Number Z-2259-2013
Recall Event ID 66276
Premarket Notification
510(K) Number
K001899 
Product Classification Material, Tooth Shade, Resin - Product Code EBF
Product NX3 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.
Recalling Firm/
Manufacturer
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
1717 W Collins Ave
Orange, California 92867-5422
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action Kerr 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 Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = EBF and Original Applicant = SYBRON DENTAL SPECIALTIES, INC.
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