Device Recall UJoint Hex Head Driver

  • Modèle / numéro de série
    Lot numbers 1365304, 1365305.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution-including the states of AZ, CA, FL, MI, OR, TX, and UT.
  • Description du dispositif
    U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver is included in Part Number 270-9004-Escalade Acetabular Prep Kit and Part Number 228-9001-Triplus Acetabular Instrument Kit. || The Acetabular Cup System is indicated for use in total hip arthroplasty procedures where the means of cup fixation is uncemented, biological fixation. The Hex Head Drive is used to place the screw that affixes the acetabular cup to the hip 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