Mentor Texas, LP.: Medical Device Recall in 2016 - (Recall #: Z-2747-2016)

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:

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 use beyond six months.

Product Classification:

Class II

Date Initiated: August 9, 2016

Date Posted: September 14, 2016

Recall Number: Z-2747-2016

Event ID: 74895

Reason for Recall:

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

Status: Terminated

Product Quantity: 65 units

Code Information:

Lot 6981537

Distribution Pattern:

Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.

Voluntary or Mandated:

Voluntary: Firm initiated