Ultradent recalls PermaFlo Flowable Composite REF-UP 948 Shade A2 due to potential cross contamination causing non-homogeneous material. Affected units have specific lot numbers and UPC codes.
Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
Ultradent is recalling PermaFlo Flowable Composite REF-UP 948 Shade A2 because of a potential manufacturing issue that might make the composite material uneven. This could affect dental work quality and safety.
The composite material might not be evenly mixed due to cross contamination during manufacturing. This could lead to uneven dental restorations that don't bond properly with teeth, potentially causing premature failure of dental work.
Dentists and dental clinics using PermaFlo Flowable Composite REF-UP 948 Shade A2 for dental restorations are most at risk. Patients receiving dental work with this product may also be affected.
Check for the PermaFlo Flowable Composite REF-UP 948 Shade A2 product. Affected units have Lot Number BJR5W and UPC Code 8832505103918.
Verify the lot number and UPC code on the product label to confirm if it's affected.
The recall states there's a potential manufacturing issue that could make the material non-homogeneous, but it's not clear if it's unsafe for use.
The recall doesn't specify a remedy, so check the product details to see if it's affected and contact Ultradent for further guidance.
Look for Lot Number BJR5W and UPC Code 8832505103918 on the PermaFlo Flowable Composite REF-UP 948 Shade A2 product.
We’ve drafted a message you can send Ultrad: a dental brand to request your refund or repair — edit it as you like.
Subject: Recall Z-0053-2021 — Ultrad: a dental brand Ultrad: a dental brand Hello, I own a Ultrad: a dental brand that is covered by recall Z-0053-2021 from Ultrad: a dental brand. 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.
