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
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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
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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 |
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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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