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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
- Hazard
- 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
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