The Recall Desk

FDA (Devices) recall action 74899

Mentor Texas, LP. recalled 2 products on 2016-09-21

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
2016-09-21
Critical
0
Units
78

Why these products were recalled

The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.

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)··2016-09-21

    Mentor Artoura Breast Tissue Expander Recall for Packaging Error

    Mentor Texas, LP. is recalling 48 Artoura Breast Tissue Expanders because CPX4 devices may have been packaged in Artoura boxes.

    Product
    Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-09-21

    Mentor CPX4 Breast Tissue Expander Recall Due to Packaging Error

    Mentor Texas, LP. is recalling 30 units of CPX4 Breast Tissue Expanders because they may have been packaged in the wrong box.

    Product
    CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular…
    Category
    Distribution
    0 states