Device Recall Micro Curved Attachment (MCA) Cutting Burr

  • Model / Serial
    All lots
  • Product Classification
  • 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
    Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA || Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
  • Manufacturer
  • 1 Event

Manufacturer

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