Sagemax recalls NexxZr T Multi A3.5 dental restorations with potential reduced dentin layer, increasing fracture risk during use. Affected units include specific model and lot numbers.
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.
Sagemax is recalling certain dental restorations that may have a thinner or missing dentin layer, making them more likely to fracture under normal use. This could lead to injury if the restoration breaks in the mouth.
The dental restorations may have a reduced or missing dentin layer, which is the protective layer between the tooth and the restoration. When subjected to normal chewing forces, this can cause the restoration to fracture, potentially leading to injury.
Dentists and patients who have received the NexxZr T Multi A3.5 dental restorations with the specific model and lot numbers listed. Patients with dental restorations that fracture easily are at higher risk.
Check for the model 'NexxZr T Multi A3.5 W98-16mm' and lot number 'YBDGLD' on the product. The product also has a unique identifier '00842271175373'.
Look for the model number 'NexxZr T Multi A3.5 W98-16mm' and lot number 'YBDGLD' on the product.
The dental restorations may have a reduced or missing dentin layer, increasing the risk of fractures under normal use.
Check the product for the model number 'NexxZr T Multi A3.5 W98-16mm' and lot number 'YBDGLD'. If you have the product, contact Sagemax for further instructions.
Yes, the restorations could fracture during normal use, which might cause injury to the patient.
We’ve drafted a message you can send Sagemax to request your refund or repair — edit it as you like.
Subject: Recall Z-2356-2026 — Sagemax Sagemax Hello, I own a Sagemax that is covered by recall Z-2356-2026 from Sagemax. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.