The Recall Desk

FDA (Devices) recall action 77950

Mako Surgical Corporation recalled 2 products on 2017-09-20

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2017-09-20
Critical
0
Units
—

Why these products were recalled

Software discrepancy of not showing all the EE constants, when the screen is filled.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2017-09-20

    Mako Surgical Recalls Robotic Arm Interactive Orthopedic System Software

    Mako Surgical Corporation is recalling the Total Hip Application software for the RIO system due to a display error that may hide essential constants.

    Product
    Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
    Category
    Distribution
    44 states
  • HighFDA (Devices)··2017-09-20

    Mako Surgical Recalls Robotic Knee System Due to Software Display Error

    Mako Surgical Corporation is recalling the Makoplasty Partial Knee Application software because it may fail to display all necessary constants when the screen is full.

    Product
    Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic
    Category
    Distribution
    44 states