Reported Feb 28, 2024 · Ongoing

Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement

Voco GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Voco GmbH · Anton-Flettner-Str. 1-3 · Cuxhaven, N/A · N/A

Is this the product you have?

  • Ionolux
  • Catalog (REF) Numbers
    • a) 2115
    • b)2117
    • c) 2118
    • d) 2119
    • e) 2120
    • f) 2122
    • dental cement
Lot codes and dates

6 of 6 products

Products covered by this recall
#Product as published
12346779, 2401515
22117, UDI/DI +E22121171, Lot Numbers: 2347832
32118, UDI/DI +E22121181, Lot Numbers: 2349536
42119, UDI/DI +E22121191, Lot Numbers: 2348501
52120, UDI/DI +E22121201, Lot Numbers: 2350638
62122, UDI/DI +E22121221, Lot Numbers: 2349527
Amount recalled
1021 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Voco GmbH recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.