Class II — Voco GmbH
| Recalling firm | VOCO GMBH |
|---|---|
| Registered facility | VOCO GMBH (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive. |
| Product | VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use with methacrylate-based restorative, core build-up or luting materials. It can be applied with phosphoric acid etching (selective enamel etching or total-etch) of the dental hard tissue as well as without (self-etch). A1] Adhesive for direct restorations of all classes of cavities using light-curing composite /compomer / Ormocer materials with a methacrylate base. [A2] Adhesive for core build-ups made of light-curing composite materials. [A3] Adhesive for indirect restorations with light… |
| Quantity | 50 units |
| Distribution | Nationwide Distribution to FL, IA, NH, PA, SC and TX |
| Initiated | 2016-11-03 |
| Classified | 2017-01-06 |
| Terminated | 2017-08-23 |
| Recall number | Z-0955-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Voco GmbH (Z-0955-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75782/
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