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U.S. Department of Health and Human Services

Class 3 Device Recall Luminesse PMMA

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  Class 3 Device Recall Luminesse PMMA see related information
Date Initiated by Firm October 09, 2020
Create Date December 01, 2020
Recall Status1 Terminated 3 on August 17, 2022
Recall Number Z-0512-2021
Recall Event ID 86614
510(K)Number K142371  
Product Classification Crown and bridge, temporary, resin - Product Code EBG
Product Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely used by a Trained Dental Technician or on the order of a dental professional.
Code Information Lot No. 1BKI
Recalling Firm/
Manufacturer		 Talladium Inc
27360 Muirfield Ln
Valencia CA 91355-1010
For Additional Information Contact
661-295-0900
Manufacturer Reason
for Recall		 Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and bridge restorations has incorrect label. label states Part no. 5336-B1 (98x20mm). However, the item inside the box was Part no. 4302-B1 (95x20mm). An incorrect label may result in compatibility issues when setting up the disc with milling machine fixtures due to size variation.
FDA Determined
Cause 2		 Labeling mix-ups
Action On 10/09/20, Urgent Medical Device Recall notices were mailed and/or emailed to customers. Customers were asked to do the following: 1) Check your stock and quarantine the affected stock on hand to prevent further use. 2) Using the provided customer letter and Recall Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3) Return product, complete the enclosed Recall Acknowledgement Form, scan and email to productrecall@talladium.com Complete the attached Acknowledgement form even if you do not have any affected stock, scan and email. The following contact information was provided: 800-221-6449 and www.TALLADIUM.com
Quantity in Commerce 10
Distribution U.S. Nationwide distribution including in the states of PA, KS, OR, FL, CA.
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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