Device Recall Formula 180 Shaver Hand Control

  • Modèle / numéro de série
    Formula Shaver Hand Control, PN 375-704-500 and Formula 180 (PN 375-708-500). Serial numbers: 12B037204, 12B037214, 12B037224, 12B037234, 12B040594, 12B040604, 12B040614, 12B040624, 12B040634, 12B040644, 12B040654, 12B040664, 12B040684, 12B041374, 12B046934, 12B046964, 12B046974, 12B046994, 12B047004, 12B047014, 12B047024, 12B047034, 12B047054, 12B047064, 12B047074, 12B047084, 12B047094, 12B049204, 12B049234, 12B049244, 12B055744, 12B055754, 12B055764, 12B055774.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: CA, FL, IA , MI, NV, NC, OK, TX, and WI; and countries of: China and Great Britain.
  • Description du dispositif
    Formula Shaver Handpiece (with buttons); || Formula 180 Shaver Handpiece (with button) || Rx only, Made USA.: || Stryker Endoscopy || 5900 Optical Court || San Jose, CA 95138 || Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Société-mère du fabricant (2017)
  • Source
    USFDA