Devices

Device Recall 1MM Fluted Ball, 7.3CM

  • Modèle / numéro de série
    All lots are included in recall
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.
  • Description du dispositif
    MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. || Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
  • Manufacturer
    The Anspach Effort, Inc.
  • 1 Event

Fabricant

The Anspach Effort, Inc.
  • Adresse du fabricant
    The Anspach Effort, Inc., 4500 Riverside Drive, Palm Beach Gardens FL 33410-4235
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA