Recall Z-1143-2024 ยท EMA Cement, Dental
Voco GmbH
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
| Date | Feb 16, 2024 (initiated Jan 25, 2024) |
| Status | Open, Classified |
| 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 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 | 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 m.cyll@voco.de. |
| Quantity | 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, Switzerlan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090817 | IONOLUX Voco GmbH, Jul 23, 2009 |