Device recall
Z-2069-2014: Calcium Hydroxide Powder, USP For use in root canal therapy by health care…
FDA device recall · Class II · Axcentria Pharmaceuticals, LLC
Key facts
| Recall number (Z-number) | Z-2069-2014 |
|---|---|
| Recall event | 68480 |
| 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… |
| Product code | EJK |
| Recalling firm | Axcentria Pharmaceuticals, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 28, 2016 |
| FEI number | 3008062657 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database