Paltop Advanced Dental Solutions Ltd recalls Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020

Recall date

November 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0836-2020

FDA classification

Class II

Brand / firm

Paltop Advanced Dental Solutions Ltd

Sold / distributed

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

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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