Ionolux dental cement recalled for manufacturing defect affecting curing
Ionolux dental cement capsules may contain incorrect plungers that prevent proper curing. Affected batches distributed in the US and internationally should not be used.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with manufacturing defect affecting product functionality. No illnesses or injuries have been reported. The defect prevents proper curing of dental material, creating risk of treatment failure, but the hazard remains theoretical pending reported adverse events.
Plain-English summary
Voco GmbH has recalled Ionolux dental cement in capsule form (catalog numbers 2115, 2117, 2118, 2119, 2120, and 2122) due to a manufacturing defect. The recall affects 1021 units worldwide.
During manufacturing, some capsules received an incorrect plunger that does not contain the correct reactive component needed for Ionolux to cure properly. When these affected capsules are activated, curing is significantly delayed and incomplete, making it impossible to process the material according to the manufacturer's instructions.
The affected dental cement has been distributed in the United States (Iowa, New York, Pennsylvania, and Washington) and internationally to Belgium, Bulgaria, Denmark, Germany, France, Greece, Great Britain, India, Italy, Canada, Qatar, Lithuania, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Sweden, Switzerland, Slovakia, Spain, Czech Republic, Australia, Saudi Arabia, and Ireland.
Dental professionals who have received Ionolux cement from the affected lot numbers should stop using the product immediately and contact Voco GmbH. Patients who received dental work using affected material should contact their dental provider to discuss potential replacement or repair of the restoration.
The recalled product
- Product
- Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
- Manufacturer
- Voco GmbH
- Category
- Medical Device — Dental Cement
- Hazard
- manufacturing-defect
- product-dysfunction
- incomplete-curing
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- 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
Distribution
Distributed in 4 states:
- IA
- NY
- PA
- WA
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