Recall Z-0512-2021 ยท EBG Crown And Bridge, Temporary, Resin
Talladium Inc
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.
| Date | Oct 9, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 ha |
| Quantity | 10 |
| Distribution | U.S. Nationwide distribution including in the states of PA, KS, OR, FL, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142371 | Luminesse PMMA Talladium, Inc., Apr 24, 2015 |