Scan Abutment NP — Class II medical device recall Z-0014-2022
Terminated recall by Paltop Advanced Dental Solutions Ltd, reported 2021-10-13, distributed nationwide. Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the
| Recall number | Z-0014-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Paltop Advanced Dental Solutions Ltd, Caesarea, Israel |
| Recall initiated | 2021-07-26 |
| Classified | 2021-10-04 |
| Reported by FDA | 2021-10-13 |
| Terminated | 2023-09-21 |
| Distributed | Nationwide (US) |
| Quantity | 354 |
| Model numbers | 30-70102 |
Product
Scan Abutment NP, Cat. No. 30-70102 - 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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0014-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.