Device Recall Robotic Arm Interactive Orthopedic System (RIO)

  • Model / Serial
    All lots, Part Numbers: 201000, 203999, 207300, and 209930.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii.
  • Product Description
    Restoris Partial Knee Application (PKA) RIO (TGS 2.0). || For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Mako Surgical Corporation, 2555 Davie Rd Ste 110, Plantation FL 33317-7424
  • Manufacturer Parent Company (2017)
  • Source
    USFDA