Sagemax Bioceramics, Inc.
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A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
NexxZr T Multi A3.5 W98-16mm, REF: 745451
UDI-DI: 00842271175373, Lot: YBDGLD
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →