Talladium recalls Luminesse ML PMMA milling blanks with incorrect labels that may cause compatibility issues when used with dental milling machines. Affected units have Part no. 4302-B1 (95x20mm) but labeled as 5336-B1 (98x20mm).
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.
Talladium recalls Luminesse ML PMMA milling blanks that have the wrong label. This could cause problems when setting up the blank with dental milling machines because the actual size differs from what's labeled. If you use these blanks, you might have issues making temporary dental crowns or bridges.
The milling blanks are labeled as 98x20mm (Part no. 5336-B1) but actually measure 95x20mm (Part no. 4302-B1). This size difference could cause compatibility issues when attaching the blank to dental milling machines, potentially leading to improper fit or function during fabrication.
Dental technicians and dentists who use Luminesse ML PMMA milling blanks for temporary crowns and bridges. Those who have the specific lot number 1BKI are most at risk.
Check if your Luminesse ML PMMA blank has a label stating Part no. 5336-B1 (98x20mm) but is actually Part no. 4302-B1 (95x20mm). Affected units were sold with Lot No. 1BKI.
Verify the part number on the label matches the actual product (Part no. 4302-B1 for 95x20mm).
The Luminesse ML PMMA milling blanks have an incorrect label that states Part no. 5336-B1 (98x20mm) but are actually Part no. 4302-B1 (95x20mm). This size difference could cause compatibility issues with dental milling machines.
Check the label on your Luminesse ML PMMA blank to see if it matches Part no. 4302-B1 (95x20mm). If it does, you can continue using it but be aware of potential compatibility issues with dental milling machines.
The official recall does not provide a fix; the remedy is not stated in the record.
We’ve drafted a message you can send Talladium to request your refund or repair — edit it as you like.
Subject: Recall Z-0512-2021 — Talladium Talladium Hello, I own a Talladium that is covered by recall Z-0512-2021 from Talladium. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
