The Recall Desk

FDA (Devices) recall action 74895

Mentor Texas, LP. recalled 2 products on 2016-09-14

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-09-14
Critical
0
Units
135

Why these products were recalled

Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2016-09-14

    Mentor Breast Tissue Expanders Recalled Due to Product Mix-Up

    Mentor Texas, LP. is recalling 65 units of MENTOR CPX4 breast tissue expanders because a 350cc unit was found in a carton intended for 450cc units.

    Product
    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 temporary subcutaneous or submuscular implantation and are not intended for u
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-09-14

    Mentor CPX4 Breast Tissue Expanders Recalled for Product Mix-Up

    Mentor Texas, LP. is recalling 70 units of CPX4 breast tissue expanders because a 350cc product was found in a carton labeled for the 450cc version.

    Product
    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 temporary subcutaneous or submuscular implantation and are not intended for u
    Category
    Distribution
    0 states