Mentor Texas, LP.

FDA Regulatory Profile

Summary

Total Recalls
16
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1681-2026Class IICPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SFebruary 18, 2026
Z-1684-2026Class IICPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-1February 18, 2026
Z-1687-2026Class IIArtoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UFebruary 18, 2026
Z-1682-2026Class IICPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height February 18, 2026
Z-1685-2026Class IIArtoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135February 18, 2026
Z-1686-2026Class IIArtoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDCFebruary 18, 2026
Z-1683-2026Class IICPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-12February 18, 2026
Z-0367-2022Class IIMENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elasSeptember 30, 2021
Z-2070-2017Class IIMentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-March 27, 2017
Z-2781-2016Class IICPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconAugust 9, 2016
Z-2748-2016Class IIMENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture TabAugust 9, 2016
Z-2747-2016Class IIMENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture TabAugust 9, 2016
Z-2780-2016Class IIArtoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast recAugust 9, 2016
Z-2326-2016Class IIMentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstrucJuly 1, 2016
Z-0964-2015Class IIMENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.December 11, 2014
Z-2591-2014Class IIEN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast ImplantJuly 2, 2014