Drug recall
Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of…
FDA recall event 74722 · Class II · Anthogyr
Key facts
| Event ID | 74722 |
|---|---|
| Recall numbers | Z-2753-2016, Z-2754-2016 |
| Recalling firm | Anthogyr |
| Product type | Devices |
| Products | Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of…, Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Following a FDA inspection showing that the firm failed to validate the design and process of its implants. |
| Initiation date | Jun 20, 2016 |
| Report date | Sep 14, 2016 |
| Termination date | Mar 28, 2017 |
| City | Sallanches |
| Country | France |
| FEI number | 4224 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: