Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
Recall
- Recall Number
- Z-0836-2020
- Event Number
- 84412
- Firm
- Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel
- FEI Number
- 3009161350
- Product Code
- DZE
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- November 18, 2019
- Terminated
- December 27, 2022
Description
Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
Some of the implants were packaged with a Standard Platform Cover Screw instead of a Narrow Platform Cover Screw. The Standard Platform Cover Screw will not fit in the Narrow Platform implant.
Urgent: Medical Device Recall notification letters dated 11/18/19 were sent to customers. Please discontinue use. Attached is a Reply Communication form that should be used to let us know whether the product has been used or will be returned. Once we receive that Form, a Customer Service agent will reach out to you with return instructions and provide a label if necessary. Paltop Advanced Dental will replace the implants that are in stock.
The products were distributed to the following US states: CA, DC, FL, GA, MA, MD, NJ, NY, SC, TX, and VA.
67