FDA Device recall Z-0211-2024
Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #…
- FDA Device
- Class II
- ongoing
- Published 2023-11-08
On 2023-11-08 the FDA classified a Class II recall of Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #… by Cosmedent, citing reports were received the elastomer cup material is crumbling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0211-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-20 |
| Published | 2023-11-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cosmedent |
| Distribution | US |
Product
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.
Identifiers
| code_info | Lot numbers 464948, 465769, 467512, 470596, 477493, 478610, 479776, 482382, 484262, and 484781; UDI-DI D77940310111. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0211-2024%22
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