Drug recall
SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement…
FDA recall event 70507 · Class II · DePuy Orthopaedics, Inc.
Key facts
| Event ID | 70507 |
|---|---|
| Recall numbers | Z-1246-2015 |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Product type | Devices |
| Products | SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed. |
| Initiation date | Feb 11, 2015 |
| Report date | Mar 11, 2015 |
| Termination date | May 19, 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: