Device recall
Z-0174-2015: Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article…
FDA device recall · Class II · Straumann USA, LLC
Key facts
| Recall number (Z-number) | Z-0174-2015 |
|---|---|
| Recall event | 69454 |
| Product | Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients… |
| Product code | DZE |
| Recalling firm | Straumann USA, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 26, 2017 |
| 510(k) numbers | K121131 |
| 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