Recall Z-2781-2016— Mentor Texas, LP.

Name: FDA recall Z-2781-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-09

Class II · Terminated

Class II FDA medical device recall by Mentor Texas, LP., initiated 2016-08-09, terminated 2017-03-08. It names one FDA 510(k) clearance: K130813. 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 implantation and are not intended for use beyond six months.. Reason: The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box..

Recalling firm: Mentor Texas, LP.
Classification: Class II
Status: Terminated
Initiated: 2016-08-09
Terminated: 2017-03-08
Firm location: Irving, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K130813 — MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSMentor Corp.·cleared 2013-04-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 implantation and are not intended for use beyond six months.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.