Drug recall
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
FDA recall event 65209 · Class II · Biomet, Inc.
Key facts
| Event ID | 65209 |
|---|---|
| Recall numbers | Z-1465-2013 |
| Recalling firm | Biomet, Inc. |
| Product type | Devices |
| Products | Active Articulation E1. Intended for use with either primary or revision hip arthroplasty. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes… |
| Initiation date | Apr 26, 2013 |
| Report date | Jun 12, 2013 |
| Termination date | Aug 29, 2013 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1825034 |
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: