Recall Z-0973-2013 ยท NDP Accessories, Implant, Dental, Endosseous
Keystone Dental Inc
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
| Date | Mar 20, 2013 (initiated Mar 11, 2013) |
| Status | Terminated |
| Reason | Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled |
| Root cause | Packaging process control |
| Action | Keystone Dental initially called customers on 3/11/13 and forms were completed to document these calls. In addition, a letter sent via Federal Express/or hand delivered to all distributors and customers. Product requested to be returned. |
| Quantity | 120 units |
| Distribution | Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051614 | PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS Lifecore Biomedical, Inc., Sep 9, 2005 |