Drug recall
MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast…
FDA recall event 74895 · Class II · Mentor Texas, LP.
Key facts
| Event ID | 74895 |
|---|---|
| Recall numbers | Z-2747-2016, Z-2748-2016 |
| Recalling firm | Mentor Texas, LP. |
| Product type | Devices |
| Products | MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for…, MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc |
| Initiation date | Aug 9, 2016 |
| Report date | Sep 14, 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: