Device recall
Z-0455-2019: Neodent GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are…
FDA device recall · Class II · Straumann Manufacturing, Inc.
Key facts
| Recall number (Z-number) | Z-0455-2019 |
|---|---|
| Recall event | 81456 |
| Product | Neodent GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match… |
| Product code | DZE |
| Recalling firm | Straumann Manufacturing, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 28, 2019 |
| 510(k) numbers | K163194 |
| FEI number | 1000121052 |
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