Events

Recall of Device Recall MAKO RIO Standard System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mako Surgical Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77553
  • Event Risk Class
    Class 2
  • Event Number
    Z-2741-2017
  • Event Initiated Date
    2017-06-07
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156493
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Orthopedic stereotaxic instrument - Product Code OLO
  • Reason
    An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
  • Action
    Customers were sent notices titled "Urgent Medical Device Correction Notification" on 06/12/2017 via UPS Next Day Mail. The firm notifies consignees of the reason for recall and instructs that users of the recalled product be provided the recall notice. Users may continue to use their MAKO system; and, Stryker/MAKO Service personnel will contact users o schedule time to inspect and replace the card cage, if necessary. Also, users are instructed to return the completed Business Reply Form within 5 business days. The completed form can be sent to strykerortho7391@stericycle.com or faxed to 855-544-4807. Any questions can be directed to Clayton Odor at 954-628-0502.

Device

Device Recall MAKO RIO Standard System
  • Model / Serial
    Lot No. 05212015
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.
  • Product Description
    MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. || Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
  • Manufacturer
    Mako Surgical Corporation

Manufacturer

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