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U.S. Department of Health and Human Services

Class 2 Device Recall Scan Abutment SU

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  Class 2 Device Recall Scan Abutment SU see related information
Date Initiated by Firm July 26, 2021
Create Date October 04, 2021
Recall Status1 Terminated 3 on September 21, 2023
Recall Number Z-0016-2022
Recall Event ID 88576
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
Product Scan Abutment SU, Cat. No. 30-70104 - 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.
Code Information All lots manufactured prior to July 21, 2021.
Recalling Firm/
Manufacturer
Paltop Advanced Dental Solutions Ltd
5, Ha-Shita
Caesarea Israel
For Additional Information Contact Customer Service
866-902-9272
Manufacturer 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.
FDA Determined
Cause 2
Process change control
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.
Quantity in Commerce 16
Distribution US Nationwide distribution. No foreign distribution from US.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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