# FDA recall Z-1143-2024

> **Voco GmbH** · Class II · device recall initiated 2024-01-25.

## Product

Ionolux, Catalog (REF) Numbers:  a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement

## Reason for recall

Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.

## Distribution

Worldwide distribution: US distribution to states of:  IA, NY, PA, WA; and OUS (foreign) to countries of: Belgium, Bulgaria, Denmark, Germany, France, Greece, Great Britain, India, Italy, Canada, Quatar, Lithuania, Netherlands, Northern Ireland, Norway,  Poland, Portugal, Romania, Sweden, Switzerland, Slovakia, Spain, Czech Republic, Australia, Saudi Arabia, & Ireland.

## Key facts

- **Recall number:** Z-1143-2024
- **Recalling firm:** Voco GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-25
- **Report date:** 2024-02-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cuxhaven, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1143-2024

## Citation

> AI Analytics. FDA recall Z-1143-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1143-2024. Source: US FDA. Licensed CC0.

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