Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
This recall has been terminated (originally issued September 28, 2017).
- Company
- Cosmedent, Inc.
- Recall Initiated
- September 28, 2017
- Terminated
- October 5, 2020
- Recall Number
- Z-0741-2018
- Quantity
- 84 units
- Firm Location
- Chicago, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Distribution
Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.
Lot / Code Info
SKU #663-103, Lot No. 164222A, Exp. Date 10/31/2019
Root Cause
Under Investigation by firm
Action Taken
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.