Z-2943-2020 Class II Terminated
FDA device recall Z-2943-2020 was initiated by Talladium Inc on August 6, 2020 and is designated Class II. Reason for recall: 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 shrin… The recall status is terminated (terminated October 7, 2022). Affected quantity: 39 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- September 16, 2020
- Initiation Date
- August 6, 2020
- Termination Date
- October 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39 pieces
Product Description
Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks.
Reason for Recall
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.
Distribution Pattern
U.S. Nationwide distribution including in the states of CA, FL, KS, LA, MO, and PA. No OUS Consignees.
Code Information
Lot Number.: 1AZG