Scan Abutment SP, Cat. No. 30-70101 - 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.
FDA Recall Z-0013-2022 · Posted None
Recalling FirmPaltop Advanced Dental Solutions Ltd
Recall StatusTerminated
Product CodeNDP
Date Initiated2021-07-26
Date Terminated2023-09-21
Product Quantity782
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.
Firm Action
Impacted customers were contacted on July 26, 2021 via overnight delivery of written notification. The firm is replacing all components listed in the recall, purchased prior to 7/21/2021.
Customers were asked to complete and return the provided product replacement form. A customer service representative will contact you to evaluate your inventory and to facilitate the exchange immediately.
Please contact your Customer Service Department at 866-902-9272 for any questions.
Root Cause
Process change control
Distribution Pattern
US Nationwide distribution. No foreign distribution from US.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.