Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
Reported: February 28, 2024 Initiated: January 25, 2024 #Z-1143-2024
Product Description
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
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.
Details
- Recalling Firm
- Voco GmbH
- Units Affected
- 1021 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.
- Location
- Cuxhaven, N/A
Frequently Asked Questions
What product was recalled? ▼
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement. Recalled by Voco GmbH. Units affected: 1021 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 28, 2024. Severity: Moderate. Recall number: Z-1143-2024.
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