Devices

Device Recall 1.5MM Fluted Ball, 5.6CM

  • Model / Serial
    All lots are included in recall
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.
  • Product Description
    MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. 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

Manufacturer

The Anspach Effort, Inc.
  • Manufacturer Address
    The Anspach Effort, Inc., 4500 Riverside Drive, Palm Beach Gardens FL 33410-4235
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA