Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Cosmedent FlexiCup

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Cosmedent FlexiCup see related information
Date Initiated by Firm July 20, 2023
Date Posted November 02, 2023
Recall Status1 Open3, Classified
Recall Number Z-0211-2024
Recall Event ID 92812
Product Classification Cup, prophylaxis - Product Code EHK
Product Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
Code Information Lot numbers 464948, 465769, 467512, 470596, 477493, 478610, 479776, 482382, 484262, and 484781; UDI-DI D77940310111.
Recalling Firm/
Manufacturer		 Cosmedent, Inc.
4646 N Ravenswood Ave
Chicago IL 60640-4510
For Additional Information Contact Ms. Mary Nowak
773-989-6844
Manufacturer Reason
for Recall		 Reports were received the elastomer cup material is crumbling.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-