Drug recall
SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet…
FDA recall event 66248 · Class II · DePuy Orthopaedics, Inc.
Key facts
| Event ID | 66248 |
|---|---|
| Recall numbers | Z-0064-2014 |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Product type | Devices |
| Products | SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The SmartSet¿ GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the US FDA. The intended use stated in the IFU for the… |
| Initiation date | Sep 16, 2013 |
| Report date | Oct 30, 2013 |
| Termination date | Feb 24, 2015 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1818910 |
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: