Recall Z-0293-2019 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
CMP Industries, Llc
Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards
| Date | Sep 12, 2018 |
| Status | Terminated |
| Reason | Foreign material in product |
| Root cause | Material/Component Contamination |
| Action | Nobilium, A Division of CMP Industries LLC notified customer by phone and certified mail on 9/12/18 advising users of the problem and to return product.. Distributors requested to notify the user level (dental laboratory who processed this material. Questions, call 518-434-3147, extension 144, M-F 8-4:30pm (Eastern). |
| Quantity | 40 units |
| Distribution | Worldwide distribution, US Nationwide in the states of CA, FL, IL, MI, NY, OK, OR, PA, TX, WA and countries of Canada and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.