United StatesNexxZr T Multi A3.5 W98-16mm dental discs (REF: 745451; UDI‑DI: 00842271175373; Lot: YBDGLD) distributed worldwide, including U.S. states CA, MO, MN, NY, FL, ID and several countries, are affected. The yttrium‑stabilized zirconium oxide discs may have a reduced or missing dentin layer, which can increase the risk of fractures under functional stress when used clinically.
What's being recalled
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Recalling firm: Sagemax Bioceramics, Inc., Federal Way, WA, United States.
How to identify it
UDI-DI: 00842271175373, Lot: YBDGLD
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)