Drug recall
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490…
FDA recall event 76868 · Class II · Mentor Texas, LP.
Key facts
| Event ID | 76868 |
|---|---|
| Recall numbers | Z-2070-2017 |
| Recalling firm | Mentor Texas, LP. |
| Product type | Devices |
| Products | Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Missing Dome Pack accessory. |
| Initiation date | Mar 27, 2017 |
| Report date | May 17, 2017 |
| Termination date | Jun 13, 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: