Device Recall Endostitch

  • Modelo / Serial
    ENDO STITCH* POLYSORB* 0 48" U/D DLU SU J4M0853X J4M0855X J5A0192X ENDO STITCH* POLYSORB* 0 48" VIO DLU SU J4L1477X ENDO STITCH*POLYSORB* 2/0 48" U/D DLU SU J5A1097X ENDO STITCH*POLYSORB* 2/0 48" VIO DLU SU J5A0702X J5A0703X J5A0704X J5A0705X J5A1206X J5A1207X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
  • Descripción del producto
    Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU SU, Item Number: || 170057; ENDO STITCH POLYSORB 2/0 48" VIO DLU SU, Item Number: 170053
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Medtronic, 60 Middletown Ave, North Haven CT 06473-3908
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA