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U.S. Department of Health and Human Services

Class 3 Device Recall Chromaclone PVS Heavy (Fast Set)

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 Class 3 Recall
Chromaclone PVS Heavy (Fast Set)
see related information
Date Posted February 13, 2013
Recall Status1 Terminated on May 30, 2013
Recall Number Z-0812-2013
Recall Event ID 64272
Premarket Notification
510(K) Number
K972027 
Product Classification Material, Impression - Product Code ELW
Product Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
Code Information Lot No. B7DS3
Recalling Firm/
Manufacturer
Ultradent Products, Inc.
505 W 10200 S
South Jordan, Utah 84095-3935
For Additional Information Contact Corey Jaseph
801-553-4420
Manufacturer Reason
for Recall
Incorrect packaging of regular set and fast set cartridges.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated February 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected products. They may continue to use product or dispose unwanted cartridges and reply back to firm indicating acknowledgement of letter and if replacement is needed. Consumers with questions can call the firm at 801-553-4420. For questions regarding this recall call 801-553-4420.
Quantity in Commerce 100 cartridges
Distribution Nationwide Distribution
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 = ELW and Original Applicant = ZHERMACK S.P.A.
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