Drug recall
Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog…
FDA recall event 69466 · Class II · Exactech, Inc.
Key facts
| Event ID | 69466 |
|---|---|
| Recall numbers | Z-0906-2015 |
| Recalling firm | Exactech, Inc. |
| Product type | Devices |
| Products | Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Mislabeled |
| Initiation date | Oct 9, 2014 |
| Report date | Jan 14, 2015 |
| Termination date | Jun 8, 2016 |
| City | Gainesville |
| State | FL |
| Country | United States |
| FEI number | 1038671 |
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: