FDA Device recall Z-0017-2022
Scan Abutment PCA, Cat
- FDA Device
- Class II
- terminated
- Published 2021-10-13
On 2021-10-13 the FDA classified a Class II recall of Scan Abutment PCA, Cat by Paltop Advanced Dental Solutions, citing 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 en….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0017-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-26 |
| Published | 2021-10-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Paltop Advanced Dental Solutions |
| Distribution | US |
Product
Scan Abutment PCA, Cat. No. 30-70105 - 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.
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.
Identifiers
| code_info | All lots manufactured prior to July 21, 2021. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0017-2022%22
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