Device Recall 45 Angle Driver

  • Model / Serial
    All lots
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including the states of CA, IN, KS, MA, NJ, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CANADA, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, PORTUGAL, and SWITZERLAND.
  • Product Description
    45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. || Model #: || P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. || The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill).
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Greatbatch Medical, 2300 Berkshire Ln N, Minneapolis MN 55441-4575
  • Manufacturer Parent Company (2017)
  • Source
    USFDA