Axcentria Pharmaceuticals, LLC: Medical Device Recall in 2014 - (Recall #: Z-2069-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 5, 2014

Date Posted: July 23, 2014

Recall Number: Z-2069-2014

Event ID: 68480

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.

Status: Terminated

Product Quantity: 528

Code Information:

lot # H13136, exp. August 2014.

Distribution Pattern:

US distribution to NY and CA

Voluntary or Mandated:

Voluntary: Firm initiated