Device Recall RIO Robot Arm Interactive Orthopedic System

  • Modelo / Serial
    Lot numbers: ROB034, ROB035, ROB036, ROB037, ROB038, ROB042, ROB044, ROB045, ROB046, ROB047, ROB048, ROB049, ROB050, ROB051, ROB053, ROB054, ROB055, ROB056, ROB057, ROB059, ROB060, ROB061, ROB062, ROB062, ROB063, ROB066, ROB067, ROB069, ROB070, ROB071, ROB072, ROB073, ROB074, ROB075, ROB076, ROB077, ROB078, ROB079, ROB080, ROB081, ROB082, ROB083, ROB084, ROB085, ROB086, ROB088, ROB093, ROB094, ROB096, ROB097, ROB098, ROB099, ROB100, ROB101, ROB102, ROB103, ROB104, ROB107, ROB108, ROB109, ROB110, ROB112, ROB114, ROB116, ROB117, ROB118, ROB120, ROB121, ROB122, ROB123, ROB124.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: USA including states of: AZ, CA, CO, FL, GA, IA, IL, LA, MI, MO, MS, NC, NJ, NV, NY, OK, OH, OR, PA, RI, TX, UT, VA, WA, WI, and WV; and countries of: Scotland, Italy and Korea.
  • Descripción del producto
    Labeling for RIO Robot Unit is comprised of three main components: 20399 RIO SURGICAL ARM, 201251 RIO GUIDANCE MODULE, 200294 RIO CAMERA STAND ASSEMBLY***PN 203999 SN ROB 125 2010-12 V 100/120/230 A 9.6/8.0/4.2 Hz 50/60 Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995 UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90.***Manufactured in USA***MAKO SURGICAL CORP. 2555 DAVIE ROAD, FT. LAUDERDALE, FL 33317. || RIO System - The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Tactile Guidance System v2.0 is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be approriate, and where reference to rigid anatomical bony structures can be identified relative to a CT base model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Mako Surgical Corporation, 2555 Davie Rd Ste 110, Davie FL 33317-7424
  • Source