PermaFlo Flowable Composite REF-UP 948 Shade: A2 — Class II medical device recall Z-0053-2021
Terminated recall by Ultradent Products, Inc., reported 2020-10-14, distributed nationwide. Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
| Recall number | Z-0053-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ultradent Products, Inc., South Jordan, UT, United States |
| Recall initiated | 2020-08-31 |
| Classified | 2020-10-02 |
| Reported by FDA | 2020-10-14 |
| Terminated | 2021-10-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, DE, JP |
| UPC / GTIN / UDI-DI | 00883205103918 |
| Lot numbers | BJR5W |
| Model numbers | 948 |
Product
PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.
Reason for recall
Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0053-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.