Recall Z-1485-2018 ยท DZE Implant, Endosseous, Root-Form
Keystone Dental Inc
Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
| Date | Mar 13, 2018 |
| Status | Terminated |
| Reason | The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette. |
| Root cause | Error in labeling |
| Action | Notification was mailed to all impacted customers on March 13, 2018, via overnight Federal Ex-press. Customer Relations will contact the customers via phone to ensure the customers received the notification, instructions, and replacement grommets. Customer Relations Reply Forms are being used to document the communication. For further questions, please call (866) 902-9272. |
| Quantity | 19 |
| Distribution | USA (nationwide) Distribution and Internationally to Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101545 | GENESIS IMPLANT SYSTEM Keystone Dental, Oct 28, 2010 |