Drug recall
MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made…
FDA recall event 88868 · Class II · Mentor Texas, LP.
Key facts
| Event ID | 88868 |
|---|---|
| Recall numbers | Z-0367-2022 |
| Recalling firm | Mentor Texas, LP. |
| Product type | Devices |
| Products | MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device. |
| Initiation date | Sep 30, 2021 |
| Report date | Dec 22, 2021 |
| 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: