Events

Recall of Device Recall Robotic Arm Interactive Orthopedic 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
    72224
  • Event Risk Class
    Class 2
  • Event Number
    Z-0224-2016
  • Event Initiated Date
    2015-07-16
  • Event Date Posted
    2015-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140274
  • 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
    The locking pin on the rio base array is damaged during assembly onto the rio base array connector.
  • Action
    As of July 16, 2015, Mako communicated by mail the nature of the recall to their Product Specialists and the OR Administrators describing the specifics regarding the issue for correction.

Device

Device Recall Robotic Arm Interactive Orthopedic System
  • Model / Serial
    Model/Catalog Numbers Affected: Mako Rio Robotic Arm (201000, 203999, 207300 and 209930. Lot/Serial Number: All RIO's.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and HI, and the countries of Italy, Japan, Hong Kong, Scotland, Germany, Turkey, Greece, Australia, Singapore, Taiwan, and South Korea.
  • Product Description
    Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.
  • Manufacturer
    Mako Surgical Corporation

Manufacturer

Mako Surgical Corporation
  • Manufacturer Address
    Mako Surgical Corporation, 2555 Davie Rd Ste 110, Plantation FL 33317-7424
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA