Cosmedent, Inc. recalls Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument,…

Recall date

July 20, 2023

Source

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

Recall number

Z-0211-2024

FDA classification

Class II

Brand / firm

Cosmedent, Inc.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Australia, Colombia, Denmark Ecuador, Estonia, Greece, Hungary, Iran, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Paraguay, Philippines, Spain, Sweden, UAE, and United Kingdom.

Why it was recalled

Reports were received the elastomer cup material is crumbling.

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

What was recalled

Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.