Device recall
Z-1854-2020: Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly…
FDA device recall · Class II · Nobel Biocare Usa Llc
Key facts
| Recall number (Z-number) | Z-1854-2020 |
|---|---|
| Recall event | 85159 |
| Product | Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. |
| Product code | NHA |
| Recalling firm | Nobel Biocare Usa Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 1, 2021 |
| 510(k) numbers | K071370 |
| FEI number | 1000125598 |
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