The Recall Desk
LowFDA (Devices)·Z-0512-2021·Announced 2020-12-09

Talladium Luminesse ML PMMA Milling Blank Recall for Incorrect Label

Talladium Inc is recalling 10 units of Luminesse ML PMMA milling blanks due to incorrect labels that may cause compatibility issues with milling machines.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a labeling error leading to potential equipment compatibility issues, not a direct health risk.

Plain-English summary

Talladium Inc is recalling 10 units of Luminesse ML PMMA milling blanks, reference number 5336-B1, lot number 1BKI. These products are used by trained dental technicians or on the order of dental professionals to fabricate provisional crowns and bridges.

The recall was initiated because the product label states Part No. 5336-B1 (98x20mm), but the item inside the box is actually Part No. 4302-B1 (95x20mm). This discrepancy in size may result in compatibility issues when setting up the disc with milling machine fixtures.

The affected products were distributed nationwide in the United States, including in Pennsylvania, Kansas, Oregon, Florida, and California. Consumers and dental professionals should stop using the affected milling blanks and contact Talladium Inc for instructions on return or replacement.

The recalled product

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.
Manufacturer
Talladium Inc
Affected units
10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot No. 1BKI

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Same manufacturer · Talladium Inc

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