Device recall
Z-1997-2009: MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm…
FDA device recall · Class II · IMTEC Corporation
Key facts
| Recall number (Z-number) | Z-1997-2009 |
|---|---|
| Recall event | 52614 |
| Product | MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant. The product is used as a endosseous dental implant. |
| Product code | KKO |
| Recalling firm | IMTEC Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 2, 2009 |
| 510(k) numbers | K081653 |
| FEI number | 1000118617 |
At a glance
- 1–9 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