Device recall
Z-0922-2007: EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component…
FDA device recall · Class II · Biomet 3i
Key facts
| Recall number (Z-number) | Z-0922-2007 |
|---|---|
| Recall event | 36616 |
| Product | EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant. |
| Product code | DZE |
| Recalling firm | Biomet 3i |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 30, 2008 |
| 510(k) numbers | K934126 |
| FEI number | 1038806 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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