Textured Breast Implants

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    UF6328, UF6330, UF6331, UM5056, UM5057, UM5059
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    WI, TN, TX, NY, AR
  • Product Description
    Style 363 Saline-Filled BIOCELL textured Breast Implants
  • Manufacturer
  • Model / Serial
    Lot#1121360, Serial#11567825, 11567826, 11567827, 11567828, 11567829, 11567830, 11567832, 11567833, 11567835, 11567836, 11567838, 11567839, 11567840, 11567841, 11567842, & 11567843.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
  • Manufacturer
  • Model / Serial
    Lot#1121514, Serial# 11567927 & 11567935
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
  • Manufacturer