Recall archive / FDA device enforcement
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement — FDA record Z-1143-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 25, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Voco GmbH
- Quantity
- 1021 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1143-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a) 2115, UDI/DI +E22121151, Lot Numbers: 2346779, 2401515; b) 2117, UDI/DI +E22121171, Lot Numbers: 2347832; c) 2118, UDI/DI +E22121181, Lot Numbers: 2349536; d) 2119, UDI/DI +E22121191, Lot Numbers: 2348501; e) 2120, UDI/DI +E22121201, Lot Numbers: 2350638; f) 2122, UDI/DI +E22121221, Lot Numbers: 2349527 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 28, 2024
- Recall initiation date
- Jan 25, 2024
- Center classification date
- Feb 16, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.