Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
Summary
The FDA issued a Class II for Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) by Voco GmbH. 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.
Details
Source
Device Recall
External ID
Z-1143-2024
Action Date
2024-02-28
Status
Ongoing
Category
device
Product Description
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
Lot/Code Info: 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
Quantity Affected: 1021 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-25
Company
Cuxhaven, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Voco GmbH has 14 FDA actions in our database, including 2 recalls and 12 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Voco GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Voco GmbH have FDA actions?
Voco GmbH has 14 FDA actions in our database, including 2 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1143-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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