Home / Recalls / Cosmedent, Inc. / Z-0741-2018

Z-0741-2018 Class II Terminated

Recalled by Cosmedent, Inc. — Chicago, IL

FDA device recall Z-0741-2018 was initiated by Cosmedent, Inc. on Sep 28, 2017 and is designated Class II. 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. The recall status is terminated (terminated Oct 5, 2020). Affected quantity: 84 units.

Recall details

Product Type: Devices
Report Date: Mar 7, 2018
Initiation Date: Sep 28, 2017
Termination Date: Oct 5, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 84 units

Product description

Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.

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 pattern

Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.

Code information

SKU #663-103, Lot No. 164222A, Exp. Date 10/31/2019

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0741-2018
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.