Z-0836-2020Class II

Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020

Name: Z-0836-2020 Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
Creator: Paltop Advanced Dental Solutions Ltd
Published: 2019-11-18
License: https://open.fda.gov/license/

Paltop Advanced Dental Solutions Ltd / initiated 2019-11-18 / Terminated / root cause: packaging

FDA source

Paltop Advanced Dental Solutions Ltd began a recall of Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020 on 2019-11-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0836-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-18
Posted: 2020-01-21
Terminated: 2022-12-27
Recalling firm: Paltop Advanced Dental Solutions Ltd
Product: Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
Product code: DZE Implant, Endosseous, Root-Form
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.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: UDI: 07290108695649; Lot Number WO-011320

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0836-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0836-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-29	2020-01-21

Product code DZE

K130462Class IIPaltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd. / cleared 2013-08-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)