Device Recall Xia 3 AntiTorque Key

  • Modèle / numéro de série
    Lot Codes (510k exempt): 07F116, 07F117, 085525, 086577, 086578, 087232, 087233, 088604.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026. || Product Usage: : || Reusable instrument used to aid in the final tightening of the spinal construct. Intended Use: The Anti-Torque Key allows the Torque Wrench to align with the tightening axis and maximizing the torque needed to lock the implant assembly during final tightening of the spinal construct.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • Société-mère du fabricant (2017)
  • Source
    USFDA