Recall Z-0019-2020 ยท DZE Implant, Endosseous, Root-Form
Paltop Advanced Dental Solutions Ltd
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
| Date | May 30, 2019 |
| Status | Terminated |
| Reason | Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant. |
| Root cause | Under Investigation by firm |
| Action | Keystone Dental Customer Relations initiated notification via phone calls to each impacted end user between May 30 and June 7, 2019. A market correction Letter issued to customers on June 11 via overnight Federal Express. Customer Relations Reply Forms are being used to document the communication and product status of each end user. Any unused Implants should be returned as soon as reasonably possible. |
| Quantity | 167 units |
| Distribution | AL AZ CA CO FL GA MA MD MO MT NJ NM NY OH SC VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112795 | PALTOP DENTAL IMPLANT SYSTEM Paltop Advanced Dental Solutions, Ltd., Apr 20, 2012 |