Drug recall
Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction…
FDA recall event 74899 · Class II · Mentor Texas, LP.
Key facts
| Event ID | 74899 |
|---|---|
| Recall numbers | Z-2780-2016, Z-2781-2016 |
| Recalling firm | Mentor Texas, LP. |
| Product type | Devices |
| Products | Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect…, CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. |
| Initiation date | Aug 9, 2016 |
| Report date | Sep 21, 2016 |
| Termination date | Mar 8, 2017 |
| City | Irving |
| State | TX |
| Country | United States |
| FEI number | 1000118360 |
At a glance
- 1–9 Products in this recall
- 10–99 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: