Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
FDA device recall Z-1143-2024 · posted 2024-02-16 · Open, Classified
Recall details
- Recalling firm
- Voco GmbH
- 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.
- Action taken
- 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 m.cyll@voco.de.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- EMA
- Quantity 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, Quata
- Date initiated
- 2024-01-25
- Date posted
- 2024-02-16
- Location
- Cuxhaven, Germany
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IONOLUX (K090817) | Voco GmbH | 2009-07-23 |