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U.S. Department of Health and Human Services

Class 2 Device Recall Fusio Liquid Dentin

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  Class 2 Device Recall Fusio Liquid Dentin see related information
Date Initiated by Firm August 19, 2010
Date Posted February 28, 2012
Recall Status1 Terminated 3 on February 28, 2012
Recall Number Z-1115-2012
Recall Event ID 61239
510(K)Number K072545  
Product Classification Material, tooth shade, resin - Product Code EBF
Product Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC.

Product Usage:
The intended use of this device is as a self-etch, self-adhesive flowable resin composite indicated for light-cured dental restorations. Applications include self-etch base liner, restorations of carious lesions, Class I, III and V cavity preparations and pitt and fissure sealant.
Code Information Lot Numbers: 3487864, 3491581
Recalling Firm/
Manufacturer
Kerr Corporation
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information Contact
714-516-7400
Manufacturer Reason
for Recall
A recall was initiated because Pentron Clinical has confirmed that the Fusio Liquid Dentin is not as flowable as ideally expected.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Pentron Clinical sent a Medical Device Recall letter dated September 8, 2010 (via USPS 1st class mail) to all affected customers. The letter identified the affected product, the reason for the recall and the actions to be taken. Customers were instructed to examine their inventory for the affected product, return any remaining in stock and complete and fax back the enclosed recall return form. Customers were advised to contact Pentron Clinical Customer Service at (800) 551-0283, (option 1) directly to handle the arrangements of a quick return and replacement.
Quantity in Commerce 382 units total (207 units in US)
Distribution Worldwide Distribution - USA (nationwide) in the countries of Austria, Bulgaria, France, Great Britain, Netherlands, Japan, Lebanon, Malaysia and South Africa.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = EBF and Original Applicant = PENTRON CLINICAL TECHNOLOGIES
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