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U.S. Department of Health and Human Services

Class 2 Device Recall Paltop Dynamic Dental Implant

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  Class 2 Device Recall Paltop Dynamic Dental Implant see related information
Date Initiated by Firm November 18, 2019
Create Date January 21, 2020
Recall Status1 Terminated 3 on December 27, 2022
Recall Number Z-0836-2020
Recall Event ID 84412
510(K)Number K130462  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
Code Information UDI: 07290108695649; Lot Number WO-011320
Recalling Firm/
Manufacturer		 Paltop Advanced Dental Solutions Ltd
5, Ha-Shita
Caesarea Israel
Manufacturer Reason
for Recall		 Some of the implants were packaged with a Standard Platform Cover Screw instead of a Narrow Platform Cover Screw. The Standard Platform Cover Screw will not fit in the Narrow Platform implant.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Urgent: Medical Device Recall notification letters dated 11/18/19 were sent to customers. Please discontinue use. Attached is a Reply Communication form that should be used to let us know whether the product has been used or will be returned. Once we receive that Form, a Customer Service agent will reach out to you with return instructions and provide a label if necessary. Paltop Advanced Dental will replace the implants that are in stock.
Quantity in Commerce 67
Distribution The products were distributed to the following US states: CA, DC, FL, GA, MA, MD, NJ, NY, SC, TX, and VA.
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.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = PALTOP ADVANCED DENTAL SOLUTIONS LTD
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