Z-0211-2024 Class II Ongoing
FDA device recall Z-0211-2024 was initiated by Cosmedent, Inc. on Jul 20, 2023 and is designated Class II. Reason for recall: Reports were received the elastomer cup material is crumbling. The recall status is ongoing. Affected quantity: 7,400 packs of 6.
Recall details
- Product Type
- Devices
- Report Date
- Nov 8, 2023
- Initiation Date
- Jul 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,400 packs of 6
Product description
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 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.
Code information
Lot numbers 464948, 465769, 467512, 470596, 477493, 478610, 479776, 482382, 484262, and 484781; UDI-DI D77940310111.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0211-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026