# FDA recall Z-0018-2022

> **Paltop Advanced Dental Solutions Ltd** · Class II · device recall initiated 2021-07-26.

## Product

Scan Abutment WP, Cat. No. 30-70106  - 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.

## Distribution

US Nationwide distribution. No foreign distribution from US.

## Key facts

- **Recall number:** Z-0018-2022
- **Recalling firm:** Paltop Advanced Dental Solutions Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-26
- **Report date:** 2021-10-13
- **Termination date:** 2023-09-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Caesarea, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0018-2022

## Citation

> AI Analytics. FDA recall Z-0018-2022. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-0018-2022. Source: US FDA. Licensed CC0.

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