Cosmedent FlexiCup Polishing System Recalled for Crumbling Elastomer Cup
Cosmedent is recalling the FlexiCup Composite Finishing & Polishing System due to reports that the elastomer cup material is crumbling. Approximately 7,400 packs distributed worldwide are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a material defect (crumbling elastomer) that poses potential risk of harm. No illnesses or injuries have been reported, placing this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Cosmedent, Inc. is recalling the FlexiCup Composite Finishing & Polishing System, Six Pack (REF #403-101). This is an autoclavable dental instrument used for composite finishing and polishing.
The recall was initiated due to reports that the elastomer cup material is crumbling.
Approximately 7,400 packs of 6 units were distributed worldwide, including in the United States and Australia, Colombia, Denmark, Ecuador, Estonia, Greece, Hungary, Iran, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Paraguay, Philippines, Spain, Sweden, the United Arab Emirates, and the United Kingdom. Affected units bear lot numbers 464948, 465769, 467512, 470596, 477493, 478610, 479776, 482382, 484262, and 484781.
The recalled product
- Product
- Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
- Manufacturer
- Cosmedent, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot numbers 464948
- 465769
- 467512
- 470596
- 477493
- 478610
- 479776
- 482382
- 484262
- and 484781
- UDI-DI D77940310111.
Distribution
Distributed nationwide across the United States.
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