Recall Z-0211-2024 ยท EHK Cup, Prophylaxis
Cosmedent, Inc.
Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
| Date | Nov 2, 2023 (initiated Jul 20, 2023) |
| Status | Open, Classified |
| 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 as |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.