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Class 2 Device Recall NX3 TryIn Gel |
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Date Initiated by Firm |
September 13, 2013 |
Date Posted |
September 19, 2013 |
Recall Status1 |
Terminated 3 on February 11, 2014 |
Recall Number |
Z-2259-2013 |
Recall Event ID |
66276 |
510(K)Number |
K001899
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Product Classification |
Material, tooth shade, resin - Product Code EBF
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Product |
NX3 Try-In Gel. The product is used as a tooth shade resin material.
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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 CA 92867-5422
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For Additional Information Contact |
714-516-7400
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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.
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FDA Determined Cause 2 |
Mixed-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
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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.
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510(K) Database |
510(K)s with Product Code = EBF and Original Applicant = SYBRON DENTAL SPECIALTIES, INC.
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