Home / Recalls / Medical Devices
Paltop Advanced Dental Solutions Ltd recalls Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical s
Recalled October 13, 2021 · FDA recall Z-0015-2022 · Paltop Advanced Dental Solutions
Hazard
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. · FDA Class II
Units
337
Sold at
US Nationwide distribution. No foreign distribution from US.
Description
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.
Product
Scan Abutment MU, Cat. No. 30-70103 - 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.
Manufacturer(s)
Paltop Advanced Dental Solutions Ltd
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →