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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = DZE
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