Events

Recall of Device Recall Journey Rolling Walker

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nova Ortho-Med Inc.

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
    75408
  • Event Risk Class
    Class 2
  • Event Number
    Z-0304-2017
  • Event Initiated Date
    2016-10-01
  • Event Date Posted
    2016-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150220
  • 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
    Walker, mechanical - Product Code ITJ
  • Reason
    Nova medical is recalling the journey rolling walker because the screws used to hold the black side support pieces to the frame can become loose over time. this can result in the locking nut coming off and the screw falling out.
  • Action
    A customer notification letter dated 10/1/16 was sent to customers to inform them that the screws used to hold the black side support pieces to the frame can become loose over time. This can result in the locking nut coming off and the screw falling out. This allows the frame support piece to detach from the walker and causes instability resulting in possible injury. The letter informs the customers of the root cause and the solution. Customers are instructed to record the serial #s of the product that have been corrected and email them to NOVA Customer Service (patricias@novajoy.com). Customers can also 1-800-557-6682 x131.

Device

Device Recall Journey Rolling Walker
  • Model / Serial
    Serial No. YA 4205RDFG004 TO YA4205RDFG0098 YZ4205BKFC0002 TO YZ4205RDFE0100
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of: CA, IN, HI, CT, UT, WA, FL, VA, WI, OH, MN, KS, MD, IL, MO, WY, MT, ME, PA, TN, MI, OR, NY, NJ, ID, NC, IA, OK, AR, VT, SC, TX
  • Product Description
    4205 Journey Rolling Walker || Product Usage: used to assist people in walking
  • Manufacturer
    Nova Ortho-Med Inc

Manufacturer

Nova Ortho-Med Inc
  • Manufacturer Address
    Nova Ortho-Med Inc, 1470 Beachey Pl, Carson CA 90746-4002
  • Manufacturer Parent Company (2017)
    Nova Ortho-Med Inc
  • Source
    USFDA