Device Recall Cable Assembly for the RIO STANDARD SYSTEM

  • Model / Serial
    Serial Numbers: ROB031 through ROB068.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    200996-Cable Assembly, Hybrid Extended Length, || 200997 Cable Assembly, Hybrid, Guidance Module, || 200998 Cable Assembly, Hybrid, UI Panel || Subcomponents for the 203000 RIO STANDARD SYSTEM || Manufactured by: MAKO Surgical, Corp. Fort Lauderdale, FL. || All three cables are integral components and are not purchased separately. || However, 200996-Cable Assembly is the only cable visible. This cable is labeled: 200996-REV-1, KSM 390634-1, SN 000001. 200997 and 200998 Cable Assembly are not visible . || 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.
  • Manufacturer
  • 1 Event

Manufacturer

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