Mentor Texas

9 recalls •

• Categories: Implants & Prosthetics, Other Medical Devices

MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available with SILTEX Textured or smooth surface shells. Each implant is supplied sterile with a disposable fill tube and reflux valve.

Class I - Dangerous

Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.

Sep 30, 2021 Implants & Prosthetics Nationwide View Details →

Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048

Class I - Dangerous

Missing Dome Pack accessory.

Mar 27, 2017 Implants & Prosthetics View Details →

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.

Class I - Dangerous

The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.

Aug 9, 2016 Implants & Prosthetics Nationwide View Details →

Artoura Breast Tissue Expander 700 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.

Class I - Dangerous

The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.

Aug 9, 2016 Implants & Prosthetics Nationwide View Details →

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.

Class I - Dangerous

Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc

Aug 9, 2016 Implants & Prosthetics Nationwide View Details →

MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 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.

Class I - Dangerous

Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc

Aug 9, 2016 Implants & Prosthetics Nationwide View Details →

Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.

Class I - Dangerous

The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.

Jul 1, 2016 Implants & Prosthetics View Details →

MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.

Class I - Dangerous

The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer.

Dec 11, 2014 Other Medical Devices View Details →

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.

Class I - Dangerous

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

Jul 2, 2014 Implants & Prosthetics Nationwide View Details →