FDA recall Z-0211-2024

Cosmedent, Inc. · Class II · device

Product

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

Reason for recall

Reports were received the elastomer cup material is crumbling.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2023-07-20
Report date
2023-11-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0211-2024