FDA Recall
Terminated
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Recall: Z-0019-2020
·
Initiated May 30, 2019
Recall
- Recall Number
- Z-0019-2020
- Event Number
- 83198
- Firm
- Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel
- FEI Number
- 3009161350
- Product Code
- DZE
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- May 30, 2019
- Terminated
- June 9, 2020
Description
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
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.
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.
Distribution
AL AZ CA CO FL GA MA MD MO MT NJ NM NY OH SC VA
Quantity
167 units