Paltop Advanced Dental Solutions Ltd: Medical Device Recall in 2021 - (Recall #: Z-0017-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 26, 2021

Date Posted: October 13, 2021

Recall Number: Z-0017-2022

Event ID: 88576

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.

Status: Terminated

Product Quantity: 68

Code Information:

All lots manufactured prior to July 21, 2021.

Distribution Pattern:

US Nationwide distribution. No foreign distribution from US.

Voluntary or Mandated:

Voluntary: Firm initiated