Talladium Recalls
2 recalls on record · September 16, 2020 to December 9, 2020 · Medical Devices
December 9, 2020Medical DevicesFDA
Talladium Inc recalls Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crow
Hazard: 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.
September 16, 2020Medical DevicesFDA
Talladium Inc recalls Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UD
Hazard: The linear shrinkage on the zirconia blank disc s part label is incorrect. The average linear shrinkage found on the product label was outside the acceptable range. The acceptable average linear shrinkage ranges between 1.225 to 1.275. The production lot being recalled has a linear shrinkage rate of 2.251 which is above the acceptable range.