Home / Recalls / Mentor Texas, LP. / Z-2781-2016

Z-2781-2016 Class II Terminated

Recalled by Mentor Texas, LP. — Irving, TX

Recall Details

Product Type
Devices
Report Date
September 21, 2016
Initiation Date
August 9, 2016
Termination Date
March 8, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30 units

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.

Distribution Pattern

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

Code Information

Lot 6947019

Other recalls by Mentor Texas, LP.

  • Z-0367-2022 Class II — MENTOR Saline-Filled Breast Implants are constructed from room temperature vulc (September 30, 2021)
  • Z-2070-2017 Class II — Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant (March 27, 2017)
  • Z-2747-2016 Class II — MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and (August 9, 2016)
  • Z-2780-2016 Class II — Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be (August 9, 2016)
  • Z-2748-2016 Class II — MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and (August 9, 2016)
  • Z-2326-2016 Class II — Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation a (July 1, 2016)
  • Z-0964-2015 Class II — MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast (December 11, 2014)
  • Z-2591-2014 Class II — EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use S (July 2, 2014)