medical Class II Updated 2023-11-08

Cosmedent, Inc. recalls Cosmedent FlexiCup Composite Finishing & Polishing System, S

Recalled Product

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

Hazard / Issue

Reports were received the elastomer cup material is crumbling.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot numbers 464948, 465769, 467512, 470596, 477493, 478610, 479776, 482382, 484262, and 484781; UDI-DI D77940310111.
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