FDA Device recall Z-2069-2014
Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional
- FDA Device
- Class II
- terminated
- Published 2014-07-23
On 2014-07-23 the FDA classified a Class II recall of Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional by Axcentria Pharmaceuticals, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2069-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-05 |
| Published | 2014-07-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Axcentria Pharmaceuticals |
| Distribution | CA, NY |
Product
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
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.
Identifiers
| code_info | lot # H13136, exp. August 2014. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2069-2014%22
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