Drug recall
BIOMET 3i Endosseous Dental Implant.
FDA recall event 67609 · Class II · Biomet 3i, LLC
Key facts
| Event ID | 67609 |
|---|---|
| Recall numbers | Z-1458-2014 |
| Recalling firm | Biomet 3i, LLC |
| Product type | Devices |
| Products | BIOMET 3i Endosseous Dental Implant. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface. |
| Initiation date | Aug 29, 2013 |
| Report date | Apr 23, 2014 |
| Termination date | Oct 17, 2014 |
| City | Palm Beach Gardens |
| State | FL |
| Country | United States |
| FEI number | 1038806 |
At a glance
- 1–9 Products in this recall
- 10–99 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: