Drug recall
EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF…
FDA recall event 69022 · Class II · Mentor Texas, LP.
Key facts
| Event ID | 69022 |
|---|---|
| Recall numbers | Z-2591-2014 |
| Recalling firm | Mentor Texas, LP. |
| Product type | Devices |
| Products | EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device labeling is stamped with 330cc and the device is actually 380cc device. |
| Initiation date | Jul 2, 2014 |
| Report date | Sep 10, 2014 |
| Termination date | Apr 6, 2015 |
| 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: