Z-0512-2021 Class III Terminated
FDA device recall Z-0512-2021 was initiated by Talladium Inc on October 9, 2020 and is designated Class III. 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, t… The recall status is terminated (terminated August 17, 2022). Affected quantity: 10.
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2020
- Initiation Date
- October 9, 2020
- Termination Date
- August 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product Description
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.
Distribution Pattern
U.S. Nationwide distribution including in the states of PA, KS, OR, FL, CA.
Code Information
Lot No. 1BKI