Recall Z-0128-06 ยท EHY Tray, Impression, Preformed
Rite-Dent Manufacturing Corp.
Product names: a) Alginate Dental Impression Material Regular Set, Cinnamon Flavor, Pink Color b) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color c) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color, Dustless d) Alginate Dental Impression Material Regular Set, Cherry Flavor, No color e) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink
| Date | Nov 5, 2005 (initiated Sep 21, 2005) |
| Status | Terminated |
| Reason | At least two of the ingredients used in the production of these products were not intended for human use. The ingredients are not listed in the master formula for these products nor are they listed on the ingredients list. |
| Root cause | Process design |
| Action | The recall letter was sent to customers during the week of 9/26/05. The letters were sent via first class mail for domestic accounts and included a response card. A letter will also be translated into Spanish for Central American customers who will be asked to destroy inventory and return any products at their site and forward confirmation to Rite-Dent of the destruction. The recall letters request that distributors contact their customers and that retailers 'make every effort to contact their accounts'. The firm will contact non-responders. Returned product will be held at Rite-Dent for |
| Quantity | 74460 LBS |
| Distribution | Distributed throughout the Continental United States and to several countries in the Caribbean and Central America. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003426 | ALGINATE IMPRESSION MATERIAL Rite-Dent Manufacturing Corp., Jan 23, 2001 |