Device recall
Z-2551-2018: ImplantDirect, Dental implants intended for use in partially and fully…
FDA device recall · Class II · Implant Direct Sybron Manufacturing, LLC
Key facts
| Recall number (Z-number) | Z-2551-2018 |
|---|---|
| Recall event | 79855 |
| Product | ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. |
| Product code | DZE |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 6, 2018 |
| 510(k) numbers | K130572 |
| FEI number | 3001617766 |
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