Devices

Device Recall Sterile BioEye Hydroxyapatite Orbital Implant and Conformer

  • Modèle / numéro de série
    Lot# 528020R - Serial Numbers: 55839, 60778, 60848, 60957, 61391, 170021, 185765, 185766, 185768, 185769, 185946, 190014, 190015, 190018, 2004053, 2004578, 209584, 209585, 209586, 209587, 209611, 209627, 209628, 209629, 209631, 170022, 170023, 190019, 190021, 190025, 220048, 222535, 53049, 62327, 223207, 240031, 240032, 240039, 240040, 240048
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    USA (MT, AL, IN, IA, NY, KY, IL, MI, and FL), Canada, Germany, and Turkey
  • Description du dispositif
    Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer
  • Manufacturer
    Integrated Orbital Implants Inc
  • 1 Event

Fabricant

Integrated Orbital Implants Inc
  • Adresse du fabricant
    Integrated Orbital Implants Inc, 12625 High Bluff Dr Ste 300, San Diego CA 92130-2054
  • Société-mère du fabricant (2017)
    Integrated Orbital Implants Inc
  • Source
    USFDA