Mentor Texas, LP.: Medical Device Recall in 2016 - (Recall #: Z-2780-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 muscular implantation and are not intended for use beyond six months.

Product Classification:

Class II

Date Initiated: August 9, 2016

Date Posted: September 21, 2016

Recall Number: Z-2780-2016

Event ID: 74899

Reason for Recall:

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

Status: Terminated

Product Quantity: 48 units

Code Information:

Lot 6944785

Distribution Pattern:

Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium

Voluntary or Mandated:

Voluntary: Firm initiated