Z-0211-2024Class II

Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing...

Name: Z-0211-2024 Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing...
Creator: Cosmedent, Inc.
Published: 2023-07-20
License: https://open.fda.gov/license/

Cosmedent, Inc. / initiated 2023-07-20 / Open, Classified

FDA source

Cosmedent, Inc. began a recall of Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx on 2023-07-20. FDA classified it as Class II and gives the reason as "Reports were received the elastomer cup material is crumbling". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0211-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-20
Posted: 2023-11-02
Recalling firm: Cosmedent, Inc.
Product: Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
Product code: EHK Cup, Prophylaxis
Reason for recall: Reports were received the elastomer cup material is crumbling.
FDA root cause: Under Investigation by firm
Action: The recalling firm issued letters dated 6/28/2023 via USPS Priority Mail on 7/7/2023 or 7/8/2023. The letter explained the reason for recall and requested the consignee immediately examine their inventory and quarantine the affected product. The consignee was to notify their customers of the recall, as well. A response form was enclosed for return via FAX or email to report the amount of product in the consignee's inventory, that the consignee understands the recall instructions, the amount of product being returned, held for return, or destroyed, and whether any adverse events have been associated with the recalled product. As a result of letter delivery issues, the firm recontacted customers on 7/13/2023 via email explaining the problem with the delivery and inserting a link into the email containing the recall letter and response form. The firm also knew on that date who did not open the emails and then called them on 7/13&14/2023, but the content of the call was not provided. On/about 7/21/2023, the firm emailed recall documents to their customers via USPS Priority Mail.
Quantity in commerce: 7,400 packs of 6
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.
Product codes and lots: Lot numbers 464948, 465769, 467512, 470596, 477493, 478610, 479776, 482382, 484262, and 484781; UDI-DI D77940310111.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0211-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0211-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-11-02

Product code EHK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)