Device recall
Z-2162-2018: Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants…
FDA device recall · Class II · Keystone Dental Inc
Key facts
| Recall number (Z-number) | Z-2162-2018 |
|---|---|
| Recall event | 80112 |
| Product | Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate… |
| Product code | DZE |
| Recalling firm | Keystone Dental Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 14, 2018 |
| 510(k) numbers | K051614 |
| FEI number | 3005990499 |
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