Device recall
Z-1101-2025:. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm. Nobel Biocare N1 TiUltra TCC RP…
FDA device recall · Class II · Nobel Biocare
Key facts
| Recall number (Z-number) | Z-1101-2025 |
|---|---|
| Recall event | 96047 |
| Product | . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental protheses to… |
| Product code | DZE |
| Recalling firm | Nobel Biocare |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K211109 |
| FEI number | 3002807692 |
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