Device product
Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
Z-0211-2024
Product summary
- Firm
- Cosmedent, Inc.
- Event
- Event 92812
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7,400 packs of 6
- Official record key
device-enforcement:Z-0211-2024
Official wording
Reason: Reports were received the elastomer cup material is crumbling.
Code information: Lot numbers 464948, 465769, 467512, 470596, 477493, 478610, 479776, 482382, 484262, and 484781; UDI-DI D77940310111.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Reports were received the elastomer cup material is crumbling.