Dental cement capsules recalled due to manufacturing defect affecting curing
IonoStar Plus dental cement capsules contain an incorrect plunger due to a manufacturing error. The defect prevents proper curing of the cement, making the product unsuitable for use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II recall with a manufacturing defect preventing proper product function. No illnesses or injuries have been reported, making the hazard theoretical. However, improper curing of dental cement represents a risk of harm to patients, as failed restorations could compromise dental integrity, satisfying the rubric criterion for High severity.
Plain-English summary
Voco GmbH is recalling IonoStar Plus dental cement capsules (catalog numbers 2540, 2543, 2544, 2545, 2546, 2547, 2549) due to a manufacturing defect. An error in the manufacturing process resulted in some capsules being fitted with an incorrect plunger that does not contain the correct reactive component for Ionolux.
When affected capsules are activated, the cement curing is significantly delayed and incomplete, preventing proper processing according to the product instructions for use. The affected units are unsuitable for dental use.
The recall affects 1530 units distributed worldwide. In the United States, affected products were distributed to Iowa, New York, Pennsylvania, and Washington. International distribution includes 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.
The recalled product
- Product
- IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
- Manufacturer
- Voco GmbH
- Affected units
- 1,530
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 (20)
- a) 2540
- UDI/DI +E22125401
- Lot Numbers: 2338699
- 2347154
- b)2543
- UDI/DI +E22125431
- Lot Numbers: 2344046
- c) 2544
- UDI/DI +E22125441
- Lot Numbers: 2342759
- 2439537
- d) 2545
- UDI/DI +E22125451
- Lot Numbers: 2348503
- e) 2546
- UDI/DI +E22125461
- Lot Numbers: 2344045
- 2349452
- f) 2547
- UDI/DI +E22125471
Distribution
Part of a larger recall action
This product is one of 2 recalled by Voco GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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