Device Recall Repose G2 Bone Screw System


  • Dirección del fabricante
    Medtronic Xomed, Inc., 6743 Southpoint Dr N, Jacksonville FL 32216-6218
  • 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

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Más información acerca de la data acá

  • Modelo / Serial
    Lot # 62450300
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    9 consignees in the continental United States.
  • Descripción del producto
    Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300. || Distributed by Medtronic Xomed, Inc. Jacksonville, Florida 32216 U.S.A. || The Repose G@ Bone Screw System is composed of the Repose Bone Screw (a miniature, self-tapping screw attached to polypropylene suture), the Repose Bone Screw Inserter (a battery operated, disposable device that deploys the screw), the Repose Suture Passer, and the Repose Tongue Retractor.
  • Manufacturer