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Terminated

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

FDA Recall Z-0836-2020 · Posted None

Recalling FirmPaltop Advanced Dental Solutions Ltd
Recall StatusTerminated
Product CodeDZE
Date Initiated2019-11-18
Date Terminated2022-12-27
Product Quantity67

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.

Firm 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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

The products were distributed to the following US states: CA, DC, FL, GA, MA, MD, NJ, NY, SC, TX, and VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130462PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANTPaltop Advanced Dental Solutions, Ltd. · 2013-08-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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