Z-1142-2024Class II

IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental...

Name: Z-1142-2024 IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental...
Creator: Voco GmbH
Published: 2024-01-25
License: https://open.fda.gov/license/

Voco GmbH / initiated 2024-01-25 / Open, Classified / root cause: manufacturing process

FDA source

Voco GmbH began a recall of IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement on 2024-01-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1142-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-25
Posted: 2024-02-16
Recalling firm: Voco GmbH
Product: IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
Product code: EMA Cement, Dental
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Voco issued a field safety notice to its consignees on 01/25/2024 via email. The notice explained the problem, risk, and requested the product be returned. Those who have sold the product were directed to notify their customers and collect the affected product. For questions contact Mr. Michael Cyll at [email protected].
Quantity in commerce: 1530 units
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.
Product codes and lots: 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, Lot Numbers: 2349453; g) 2549, UDI/DI +E22125491, Lot Numbers: 2342760, 2344016, 2344047, 2351233

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1142-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1142-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16
Z-1143-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16

Product code EMA

K160774Class IIIonoStar PlusVoco GmbH / cleared 2016-08-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)