Drug recall
Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing…
FDA recall event 92812 · Class II · Cosmedent, Inc.
Key facts
| Event ID | 92812 |
|---|---|
| Recall numbers | Z-0211-2024 |
| Recalling firm | Cosmedent, Inc. |
| Product type | Devices |
| Products | Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Reports were received the elastomer cup material is crumbling. |
| Initiation date | Jul 20, 2023 |
| Report date | Nov 8, 2023 |
| City | Chicago |
| State | IL |
| Country | United States |
| FEI number | 1450653 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: