Sagemax Bioceramics, Inc.: Powder, Porcelain
Recall Summary Sagemax Bioceramics is recalling NexxZr T Multi A3.5 W98-16mm porcelain discs used in dental crowns and bridges because some discs may be missing or have a thin dentin layer, which increases the risk of the restoration breaking when chewing. The recall affects dental offices and labs in the United States and multiple countries worldwide.
- Recalling firm
- Sagemax Bioceramics, Inc.
- Product
- NexxZr T Multi A3.5 W98-16mm, REF: 745451
- Reason
- Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2025-12-11
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, MO, MN, NY, FL, ID and the countries of AT, CZ, DE, EE, EG, FR, GR, ID, IT, KZ, RS, SE, SI, TZ, VN.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/de4bb732-22e4-4dbe-a4b1-51519a97b7d6