Lynx™ System, Suprapubic Sling, Obtryx™ System

  • Modèle / numéro de série
    Model Number: viz seznam soucasti FSN Product Description UPN AdvantageTM System M0068502000 AdvantageTM System, 5-Pack M006850200051 Advantage FitTM System M0068502110 Advantage FitTM System, 5-Pack M0068502111 LynxTM System M0068503000 LynxTM System, 5-Pack M0068503001 ObtryxTM System, Curved M0068504000 ObtryxTM System, Curved 5-Pack M0068504001 ObtryxTM System, Halo M0068505000 ObtryxTM System, Halo 5-Pack M0068505001 ObtryxTM II System with PrecisionBlueTM Design, Curved M0068504110 ObtryxTM II System with PrecisionBlueTM Design, Curved 5-Pack M0068504111 ObtryxTM II System with PrecisionBlueTM Design, Halo M0068505110 ObtryxTM II System with PrecisionBlueTM Design, Halo 5-Pack M0068505111 Solyx™ SIS System M0068507000 Solyx™ SIS System, 5-Pack M0068507001 UpholdTM LITE Vaginal Support System with CapioTM SLIM M0068318170 PinnacleTM LITE Pelvic Floor Repair Kit, Posterior with CapioTM SLIM M0068318150 UpsylonTM Y Mesh Kit with ColpassistTM Vaginal Positioning Device M0068318220 Product Description UPN XenformTM Soft Tissue Repair Matrix, 2cm x 7cm M0068302410 XenformTM Soft Tissue Repair Matrix, 4cm x 7cm M0068302430 XenformTM Soft Tissue Repair Matrix, 6cm x 10cm M0068302450 XenformTM Soft Tissue Repair Matrix, 8cm x 12cm M0068302470
  • Description du dispositif
    Inactive implantable medical devices
  • Manufacturer
  • 1 Event

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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
    MHSIDCCCDMIS