FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2069-2014
- Recalling firm
- Axcentria Pharmaceuticals, LLC
- 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.
- Status
- Terminated
- Initiated
- 2014-06-05
- Posted
- 2014-07-16
- Terminated
- 2016-11-28
- 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
- Lot, serial or model codes
- lot # H13136, exp. August 2014.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EJK
- Firm FEI
- 3008062657
- Firm city
- Telford
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28