Recall Z-2069-2014 ยท EJK Liner, Cavity, Calcium Hydroxide
Axcentria Pharmaceuticals, LLC
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.
| Date | Jul 16, 2014 (initiated Jun 5, 2014) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 528 |
| Distribution | US distribution to NY and CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.