Device recall
Z-0839-2015: Neodent Titamax WS Cortical Implant 4.0 x 5 mm (Endosseous dental implant)…
FDA device recall · Class II · Instradent USA, Inc.
Key facts
| Recall number (Z-number) | Z-0839-2015 |
|---|---|
| Recall event | 69835 |
| Product | Neodent Titamax WS Cortical Implant 4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 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… |
| Product code | DZE |
| Recalling firm | Instradent USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 6, 2015 |
| FEI number | 1000121052 |
At a glance
- None 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