Recall Z-0836-2020 ยท DZE Implant, Endosseous, Root-Form
Paltop Advanced Dental Solutions Ltd
Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
| Date | Nov 18, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Mixed-up of materials/components |
| Action | 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. |
| Quantity | 67 |
| Distribution | The products were distributed to the following US states: CA, DC, FL, GA, MA, MD, NJ, NY, SC, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130462 | PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT Paltop Advanced Dental Solutions, Ltd., Aug 27, 2013 |