Drug recall
Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable)…
FDA recall event 75119 · Class II · Osteogenics Biomedical, Inc.
Key facts
| Event ID | 75119 |
|---|---|
| Recall numbers | Z-0113-2017 |
| Recalling firm | Osteogenics Biomedical, Inc. |
| Product type | Devices |
| Products | Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device has the potential to be packaged in the wrong product box. |
| Initiation date | Sep 7, 2016 |
| Report date | Oct 26, 2016 |
| Termination date | Dec 23, 2016 |
| City | Lubbock |
| State | TX |
| Country | United States |
| FEI number | 3002253367 |
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: