Home / Recalls / Mentor Texas, LP. / Z-2748-2016

Z-2748-2016 Class II Terminated

Recalled by Mentor Texas, LP. — Irving, TX

Recall Details

Product Type
Devices
Report Date
September 14, 2016
Initiation Date
August 9, 2016
Termination Date
March 8, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
70 units

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

Distribution Pattern

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

Code Information

Lot 6981543

Other recalls by Mentor Texas, LP.

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  • Z-2070-2017 Class II — Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant (March 27, 2017)
  • Z-2780-2016 Class II — Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be (August 9, 2016)
  • Z-2747-2016 Class II — MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and (August 9, 2016)
  • Z-2781-2016 Class II — CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be u (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)