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.
- Company
- Axcentria Pharmaceuticals Llc
- Recall Initiated
- June 5, 2014
- Posted
- July 16, 2014
- Terminated
- November 28, 2016
- Recall Number
- Z-2069-2014
- Quantity
- 528
- Firm Location
- Telford, PA
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
US distribution to NY and CA
Lot / Code Info
lot # H13136, exp. August 2014.
Root Cause
No Marketing Application
Action Taken
Axcentria Pharmaceuticals sent an urgent medical device recall notice, dated June 5, 2014, was sent to customers and described the product, problem, and actions to be taken. Customers were asked to fill out and return the form included. For questions customers were instructed to call 215-453-5055, ext 317.
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