Drug recall
Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use…
FDA recall event 79268 · Class II · OMNIlife science Inc.
Key facts
| Event ID | 79268 |
|---|---|
| Recall numbers | Z-1117-2018 |
| Recalling firm | OMNIlife science Inc. |
| Product type | Devices |
| Products | Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. The improper expiration date (2202-03) is marked on the external packaging only. The… |
| Initiation date | Nov 20, 2017 |
| Report date | Mar 28, 2018 |
| Termination date | Jun 7, 2019 |
| City | Raynham |
| State | MA |
| Country | United States |
| FEI number | 3008342029 |
At a glance
- 1–9 Products in this recall
- 1–9 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: