Device recall
Z-0727-2018: Stage-1 RDS Indexed Abutment for RDS Stage-1 Single Stage Implants Keystone s…
FDA device recall · Class II · Keystone Dental Inc
Key facts
| Recall number (Z-number) | Z-0727-2018 |
|---|---|
| Recall event | 79110 |
| Product | Stage-1 RDS Indexed Abutment for RDS Stage-1 Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal… |
| Product code | DZE |
| Recalling firm | Keystone Dental Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 16, 2019 |
| 510(k) numbers | K072768 |
| 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