# FDA recall Z-0211-2024

> **Cosmedent, Inc.** · Class II · device recall initiated 2023-07-20.

## Product

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

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.

## Key facts

- **Recall number:** Z-0211-2024
- **Recalling firm:** Cosmedent, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-20
- **Report date:** 2023-11-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chicago, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0211-2024

## Citation

> AI Analytics. FDA recall Z-0211-2024. Retrieved 2026-08-22 from https://api.ai-analytics.org/recall/Z-0211-2024. Source: US FDA. Licensed CC0.

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