Device recall
Z-1351-2012: Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number…
FDA device recall · Class II · Straumann USA, LLC
Key facts
| Recall number (Z-number) | Z-1351-2012 |
|---|---|
| Recall event | 61440 |
| Product | Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. 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. Dental implants are for… |
| Product code | NDP |
| Recalling firm | Straumann USA, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 31, 2012 |
| 510(k) numbers | K033922 |
| FEI number | 1000121052 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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