Device Recall Restoris MCK Onlay Insert Extractor

  • Model / Serial
    Item No. 160430, Lot No. 19020414, 19090616, 19090915, 19100616, 19100915, 19110317, 19110616, 19110915, 19130315, 19140315, 19451016, 19461016, 19471016, 19490515, 19500515, 19510515, 19520515, 19530515, 26051212, 26070512, 26080913, 26110512, 26120512, 26130512, 26170513, 26201111, 26290412, 26330712, 26340312, 26440912.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI. Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Africa, Taiwan, Turkey, United Kingdom.
  • Product Description
    Restoris MCK Onlay Insert Extractor.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Mako Surgical Corporation, 2555 Davie Rd Ste 110, Davie FL 33317-7424
  • Source
    USFDA