Luminesse ML PMMA — Class III medical device recall Z-0512-2021
Terminated recall by Talladium Inc, reported 2020-12-09, distributed nationwide. Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and bri
| Recall number | Z-0512-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Talladium Inc, Valencia, CA, United States |
| Recall initiated | 2020-10-09 |
| Classified | 2020-12-01 |
| Reported by FDA | 2020-12-09 |
| Terminated | 2022-08-17 |
| Distributed | Nationwide (US) |
| Quantity | 10 |
| Reason classes | labeling |
| Lot numbers | 1BKI |
| Model numbers | 5336-B1 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0512-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.