Home / Recalls / Mentor Texas, LP. / Z-2591-2014

Z-2591-2014 Class II Terminated

Recalled by Mentor Texas, LP. — Irving, TX

Recall Details

Product Type
Devices
Report Date
September 10, 2014
Initiation Date
July 2, 2014
Termination Date
April 6, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34 units

Product Description

EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.

Reason for Recall

The device labeling is stamped with 330cc and the device is actually 380cc device.

Distribution Pattern

U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.

Code Information

Part Number (PN) 351-3380SZ Lot Number 6830722

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  • 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-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)