Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, M
Summary
The FDA issued a Class II for Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavabl by Cosmedent, Inc.. Reason: Reports were received the elastomer cup material is crumbling..
Details
Source
Device Recall
External ID
Z-0211-2024
Action Date
2023-11-08
Status
Ongoing
Category
device
Product Description
Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
Lot/Code Info: Lot numbers 464948, 465769, 467512, 470596, 477493, 478610, 479776, 482382, 484262, and 484781; UDI-DI D77940310111.
Quantity Affected: 7,400 packs of 6
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-20
Company
Chicago, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cosmedent, Inc. has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cosmedent, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cosmedent, Inc. have FDA actions?
Cosmedent, Inc. has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0211-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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