Device recall
Z-2828-2020: NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product…
FDA device recall · Class II · NOBEL BIOCARE SERVICES AG
Key facts
| Recall number (Z-number) | Z-2828-2020 |
|---|---|
| Recall event | 86085 |
| Product | NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function. |
| Product code | DZE |
| Recalling firm | NOBEL BIOCARE SERVICES AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 12, 2021 |
| 510(k) numbers | K073142 |
| FEI number | 3008693672 |
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