Drug recall
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in…
FDA recall event 80763 · Class II · Exactech, Inc.
Key facts
| Event ID | 80763 |
|---|---|
| Recall numbers | Z-3209-2018 |
| Recalling firm | Exactech, Inc. |
| Product type | Devices |
| Products | Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potentially have non-conforming internal threads. |
| Initiation date | May 8, 2018 |
| Report date | Sep 26, 2018 |
| 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: