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

Hazard

Reports were received the elastomer cup material is crumbling.

Details from the source

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. Quantity: 7,400 packs of 6 Lot/code info: Lot numbers 464948, 465769, 467512, 470596, 477493, 478610, 479776, 482382, 484262, and 484781; UDI-DI D77940310111.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.