Device Recall Pivot Bipolar Cup

  • Modèle / numéro de série
    Pivot Bipolar Cup 22x42mm,Part 133-2242,Lot A136254,Pivot Bipolar Cup 22x43mm,Part 133-2243,Lot A136256,Pivot Bipolar Cup 22x43mm,Part 133-2243,Lot A136255,Pivot Bipolar Cup 22x44mm,Part 133-2244,Lot A136257,Pivot Bipolar Cup 22x45mm,Part 133-2245,Lot A136258,Pivot Bipolar Cup 22x46mm,Part 133-2246,Lot A136259,Pivot Bipolar Cup 22x46mm,Part 133-2246,Lot A136260,Pivot Bipolar Cup 22x47mm,Part 133-2247,Lot A136261,Pivot Bipolar Cup 22x48mm,Part 133-2248,Lot A136262,Pivot Bipolar Cup 22x49mm,Part 133-2249,Lot A136263,Pivot Bipolar Cup 22x50mm,Part 133-2250,Lot A136265,Pivot Bipolar Cup 22x51mm,Part 133-2251,Lot A136266,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136269,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136268,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136267,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136270,
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
  • Description du dispositif
    Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY || Product Usage: || Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Ortho Development Corporation, 12187 Business Park Dr, Draper UT 84020-8663
  • Société-mère du fabricant (2017)
  • Source
    USFDA