Paltop Advanced Dental Solutions Ltd Recall 88576
Description: Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Paltop Advanced Dental Solutions Ltd Recall 88576 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0013-2022 |
| Event ID | 88576 |
| Event Description | Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Product Type | Devices |
| Distribution | US Nationwide distribution. No foreign distribution from US. |
| Quantity | 782 |
| Recall Reason | Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration. |
| Device Classification | 20211013 |
| Device Code Info | All lots manufactured prior to July 21, 2021. |
| Center Classification Date | 20211004 |
| Recall Initiation Date | 20210726 |
| Recalling Firm | Paltop Advanced Dental Solutions Ltd |
| Initial Notification | Letter |
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