Recall Z-0741-2018 ยท KLE Agent, Tooth Bonding, Resin
Cosmedent, Inc.
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
| Date | Sep 28, 2017 |
| Status | Terminated |
| Reason | Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material. |
| Root cause | Under Investigation by firm |
| Action | Customers were sent recall notification letters on approximately 09/28/2017. The letter identified the affected device and discussed the reason for the recall. Instructions included discontinuing use of the product, and returning it to Cosmedent. The firm will issue a credit or refund for the recalled device. |
| Quantity | 84 units |
| Distribution | Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052501 | MULTIPLE RESIN TOOTH BONDING AGENT Cosmedent, Inc., Oct 21, 2005 |