| Class 3 Device Recall Chromaclone PVS Heavy (Regular Set) | |
Date Initiated by Firm | February 04, 2013 |
Date Posted | February 13, 2013 |
Recall Status1 |
Terminated 3 on May 30, 2013 |
Recall Number | Z-0811-2013 |
Recall Event ID |
64272 |
510(K)Number | K972027 |
Product Classification |
Material, impression - Product Code ELW
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Product | Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics. |
Code Information |
Part No. 5012, Lot No. B7PPC |
Recalling Firm/ Manufacturer |
Ultradent Products, Inc. 505 W 10200 S South Jordan UT 84095-3935
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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 | 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 | 32 cartridges |
Distribution | Nationwide Distribution |
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 = ELW
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