FDA Enforcement
Class II
Ongoing
Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
Recall: Z-0211-2024
·
Reported November 8, 2023
Enforcement
- Recall Number
- Z-0211-2024
- Event ID
- 92812
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cosmedent, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 8, 2023
- Initiation Date
- July 20, 2023
- Classification Date
- November 2, 2023
- Address
- 4646 N Ravenswood Ave, N/A, Chicago, IL, 60640-4510, United States
Description
Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
Reason
Reports were received the elastomer cup material is crumbling.
Code Info
Lot numbers 464948, 465769, 467512, 470596, 477493, 478610, 479776, 482382, 484262, and 484781; UDI-DI D77940310111.
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