Recall Z-2748-2016— Mentor Texas, LP.

Name: FDA recall Z-2748-2016
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: 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 use beyond six months.. Reason: Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc.

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

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 use beyond six months.

Reason for recall

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

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