Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog… recallZ-0836-2020 · Paltop Advanced Dental Solutions Ltd · initiated Nov 18, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Paltop Advanced Dental Solutions Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Mixed-up of materials/components
What the company is doing
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.
Recall details
- Recall number
- Z-0836-2020
- Status
- Terminated
- Initiated by the company
- Nov 18, 2019
- Recalling firm
- Paltop Advanced Dental Solutions Ltd
- Quantity
- 67
- Product code
- DZE
- FDA submissions
- K130462
- Distribution
- The products were distributed to the following US states: CA, DC, FL, GA, MA, MD, NJ, NY, SC, TX, and VA.
Product description
Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
Code information (models, lots, serial numbers)
UDI: 07290108695649; Lot Number WO-011320
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Paltop 21-70020Paltop Advanced Dental Solutions Ltd · Implant, Endosseous, Root-Form1 recall14 reports
Other devices under the same FDA submission
7 devices cleared under K130462 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Paltop 21-70018Paltop Advanced Dental Solutions Ltd · Implant, Endosseous, Root-Form13 reports
- Paltop 21-70019Paltop Advanced Dental Solutions Ltd · Implant, Endosseous, Root-Form13 reports
- Paltop 20-70019Paltop Advanced Dental Solutions Ltd · Implant, Endosseous, Root-Form9 reports
- Paltop 20-70018Paltop Advanced Dental Solutions Ltd · Implant, Endosseous, Root-Form6 reports
- Paltop 20-70020Paltop Advanced Dental Solutions Ltd · Implant, Endosseous, Root-Form6 reports
- Paltop 21-70021Paltop Advanced Dental Solutions Ltd · Abutment, Implant, Dental, Endosseous2 reports
- Paltop 20-70021Paltop Advanced Dental Solutions Ltd · Implant, Endosseous, Root-Form1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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