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

Recalled November 8, 2023 · FDA recall Z-0211-2024 · Cosmedent

Hazard

Reports were received the elastomer cup material is crumbling. · FDA Class II

Units

7,400 packs of 6

Sold at

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.

Description

Reports were received the elastomer cup material is crumbling.

Product

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

Manufacturer(s)

Cosmedent, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →