Z-2069-2014 Class II Terminated
FDA device recall Z-2069-2014 was initiated by Axcentria Pharmaceuticals, LLC on June 5, 2014 and is designated Class II. Reason for recall: One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for use. The recall status is terminated (terminated November 28, 2016). Affected quantity: 528.
Recall Details
- Product Type
- Devices
- Report Date
- July 23, 2014
- Initiation Date
- June 5, 2014
- Termination Date
- November 28, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 528
Product Description
Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further decay. Calcium Hydroxide Powered is mixed with appropriate vehicle (i.e. Eugenol) prior to administration.
Reason for Recall
One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for use.
Distribution Pattern
US distribution to NY and CA
Code Information
lot # H13136, exp. August 2014.