Recall Z-0211-2024— Cosmedent, Inc.
Class II · Ongoing
Class II FDA medical device recall by Cosmedent, Inc., initiated 2023-07-20. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Cosmedent, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-20
- Firm location
- Chicago, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.