Mentor Texas, LP.: Medical Device Recall in 2014 - (Recall #: Z-2591-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 2, 2014

Date Posted: September 10, 2014

Recall Number: Z-2591-2014

Event ID: 69022

Reason for Recall:

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

Status: Terminated

Product Quantity: 34 units

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated