Recall Z-1997-2009 ยท KKO Ring, Teething, Fluid-Filled
IMTEC Corporation
MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant. The product is used as a endosseous dental implant.
| Date | Sep 10, 2009 (initiated Jul 7, 2009) |
| Status | Terminated |
| Reason | Size printed on product packaging does not match size of enclosed product. |
| Root cause | Other |
| Action | A notification letter dated July 7, 2009 was issued to customers. The letter described the issue and instructed customers do not use the affected product and call IMTEC, a 3M Company, at 1-800-879-9799, extension 240 for assistance. Customers were further instructed to complete the enclosed Recall Response Fax-Back Form with information on their inventory (whether or not the recalled product is in their stock). The firm's representative will follow-up with customers if no response within three business days of receiving the notification letter. |
| Quantity | 605 units |
| Distribution | Worldwide -- US, Azerbaijan, Guatemala, Turkey, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081653 | MDI MII ONE-PIECE IMPLANT, 2.9MM Imtec Corp., Sep 19, 2008 |