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Recall Observatory FDA recall evidence

Device 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.

Z-0512-2021

October 09, 2020

Class III

Product summary

Firm
Talladium Inc
Event
Event 86614
Status
Terminated
Classification
Class III
Quantity
10
Official record key
device-enforcement:Z-0512-2021

Official wording

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.

Code information: Lot No. 1BKI

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrect label