Drug recall
Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental…
FDA recall event 69835 · Class II · Instradent USA, Inc.
Key facts
| Event ID | 69835 |
|---|---|
| Recall numbers | Z-0839-2015 |
| Recalling firm | Instradent USA, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product not approved for use in the US |
| Initiation date | Aug 11, 2014 |
| Report date | Dec 31, 2014 |
| Termination date | Feb 6, 2015 |
| City | Andover |
| State | MA |
| Country | United States |
| FEI number | 3010593814 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: