Pelvic Floor Repair System

  • Model / Serial
    M0068318170, M0068318250
  • Product Description
    Indicated to reinforce tissue and stabilize the fascia structure of the pelvic floor in case of prolapse of the vaginal wall, where a surgical treatment is required, either as a mechanical reinforcement or to join material in case of fascial dysfunction.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    NIDFSINVIMA

7 devices with a similar name

Learn more about the data here

  • Model / Serial
    Uphold LITE with Capio SLIM Vaginal Support System - M0068318170
  • Manufacturer
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Non-active implants
  • Manufacturer
    AMS
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Non-active implants
  • Manufacturer
2 more