Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0512-2021 · Posted None

Recalling FirmTalladium Inc
Recall StatusTerminated
Product CodeEBG
Date Initiated2020-10-09
Date Terminated2022-08-17
Product Quantity10

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.

Firm 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 [email protected] 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

Root Cause

Labeling mix-ups

Distribution Pattern

U.S. Nationwide distribution including in the states of PA, KS, OR, FL, CA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑