Device Recall MENTOR Sterile Saline Mammary Volume Sizer

  • Model / Serial
    Part Number (PN) 351-3380SZ Lot Number 6830722
  • Product Classification
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.
  • 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Mentor Texas, LP., 3041 Skyway Cir N, Irving TX 75038-3500
  • Manufacturer Parent Company (2017)
  • Source
    USFDA