Device Recall ATEC 090912 handpiece

  • Model / Serial
    910058
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US and Puerto Rico.
  • Product Description
    ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part number 0909-12), Rx, Sterile, Suros Surgical Systems, Inc. 6100 Technology Center DR. Indianapolis, IN 46278. || The handpiece is inserted into the breast to the site of the area of interest. When the proper location/[position is achieved, the handpiece cuts and removes biopsy tissue.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Hologic, Inc., 6100 Technology Center Dr, Indianapolis IN 46278-6016
  • Manufacturer Parent Company (2017)
  • Source
    USFDA