Chicago, IL, United States
Cosmedent, Inc. recalls
2 recalls recorded since 2018, most recently on 20 July 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 July 2023
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0211-2024
- Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
Terminated Class II Medical devices
- Recall started
- 28 September 2017
- Terminated
- 5 October 2020
- Reason
- Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
- Distribution
- Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0741-2018
- Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.