FDA Medical Device Recalls (openFDA)
Cosmedent, Inc.: Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
- Recall number
- Z-0211-2024
- Recalling firm
- Cosmedent, Inc.
- Product
- Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
- Status
- Open, Classified
- Initiated
- 2023-07-20
- Posted
- 2023-11-02
- Terminated
- not on file
- Reason
- Reports were received the elastomer cup material is crumbling.
- 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
- 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.
- Lot, serial or model codes
- Lot numbers 464948, 465769, 467512, 470596, 477493, 478610, 479776, 482382, 484262, and 484781; UDI-DI D77940310111.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EHK
- Firm FEI
- 1450653
- Firm city
- Chicago
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28