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U.S. Department of Health and Human Services

Class 2 Device Recall Calcium Hydroxide Powder

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  Class 2 Device Recall Calcium Hydroxide Powder see related information
Date Initiated by Firm June 05, 2014
Date Posted July 16, 2014
Recall Status1 Terminated 3 on November 28, 2016
Recall Number Z-2069-2014
Recall Event ID 68480
Product Classification Liner, cavity, calcium hydroxide - Product Code EJK
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.
Code Information lot # H13136, exp. August 2014.
Recalling Firm/
Manufacturer		 Axcentria Pharmaceuticals, LLC
306 Keystone Dr
Unit B
Telford PA 18969
For Additional Information Contact Customer Support
215-453-5055
Manufacturer 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.
FDA Determined
Cause 2		 No Marketing Application
Action 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.
Quantity in Commerce 528
Distribution US distribution to NY and CA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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