Recall Z-1818-2017 ยท DZE Implant, Endosseous, Root-Form
Keystone Dental Inc
Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
| Date | Apr 13, 2017 (initiated Mar 9, 2017) |
| Status | Terminated |
| Reason | Straight PrimaConnex Implants contained Tapered PrimaConnex Implants |
| Root cause | Labeling mix-ups |
| Action | Keystone Dental initiated a market removal communication by telephone to customers on 3/9/2017. Customer Relations Fax Back Forms were completed to document these calls. In addition, a letter was sent via Federal Express/or hand delivered to all distributors and customers on 3/13/2017. Product returns requested and if implanted to implement healing and prosthetic protocol. Toll Free: 866-902-9272 |
| Quantity | 59 units |
| Distribution | CA, IL, IN, FL, MA, MN, NJ, NV, PA, |
| 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 |